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JUNE 2020

CLINICAL

ALERT YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS

EDITORIAL STAFF EDITOR IN CHIEF Maryam Tabatabai PharmD

TRENDING TOPICS

COVID-19 UPDATE

BEHAVIORAL HEALTH CORNER

DRUG INFORMATION HIGHLIGHTS

PIPELINE NEWS

RECENT FDA APPROVALS

EXECUTIVE EDITOR Anna Schreck Bird PharmD DEPUTY EDITORS Jessica Czechowski PharmD Lara Frick PharmD, BCPS, BCPP Carole Kerzic RPh Leslie Pittman PharmD


TRENDING TOPICS ICER ISSUES FINAL REPORT ON ACUTE MIGRAINE TREATMENTS

FARXIGA® RECEIVES INDICATION FOR USE IN HF-ONLY PATIENTS

The Institute for Clinical and Economic Review (ICER) has released a final report on acute treatments for migraine that addresses the use of lasmiditan (Reyvow®), ubrogepant (Ubrelvy™), and rimegepant (Nurtec™ ODT). All 3 of these drugs are approved by the United States (US) Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura in adults. Ubrogepant and rimegepant are from the class of agents known as calcitonin gene-related peptide (CGRP) receptor antagonists, whereas lasmiditan is a serotonin (5-HT) 1F receptor agonist. The 3 products are all taken orally, with rimegepant being available as an orally disintegrating tablet (ODT). Lasmiditan is a Schedule V controlled substance based on its potential for abuse; the other 2 agents are not controlled substances. These medications are not indicated for the preventive treatment of migraine.

In May 2020, the US FDA approved a new indication for the type 2 diabetes mellitus (T2DM) drug dapagliflozin (Farxiga; AstraZeneca) to be used for the management of heart failure (HF) patients. Dapagliflozin received approval for reduction in the risk of cardiovascular (CV) death and hospitalization for HF in adults with HF (New York Heart Association [NYHA] functional class II to IV) with reduced ejection fraction (EF). This marks the first medication in this drug class, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, to be approved for an HF-only indication without any requirement for the patient to have diabetes.

Lasmiditan, rimegepant, and ubrogepant have been evaluated in placebo-controlled clinical trials, and data suggest that each drug decreases migraine attack symptoms and leads to improved function 2 hours postdose compared to placebo. For adults with acute migraine who can tolerate triptans, ICER concluded that current evidence on these new agents was found to be inadequate for establishing superiority over triptans. However, for adult migraineurs with moderate to severe attacks who have experienced an inadequate response from nonprescription therapies and who cannot take triptans, there is moderate certainty that the drugs offer a small or substantial health benefit compared to no treatment. Per ICER, for patients who can tolerate triptans, data suggest the triptans offer similar or better efficacy than these 3 new agents. Data also suggest that rimegepant and ubrogepant have similar net health benefit, and lasmiditan likely has comparable efficacy but exhibits a higher likelihood of dizziness and discontinuation. 2 | JUNE 2020

Dapagliflozin is already indicated in T2DM patients as an adjunct to diet and exercise to improve glycemic control and to reduce the risk of hospitalization for HF in adults with T2DM and established CV disease or multiple CV risk factors. Other agents in the SGLT2 inhibitor class also indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM include canagliflozin (Invokana®), ertugliflozin (Steglatro™), and empagliflozin (Jardiance®). Empagliflozin is also indicated to reduce the risk of CV death in adults with T2DM and established CV disease, whereas canagliflozin is indicated to reduce the risk of major adverse cardiovascular events (MACE) in adults with T2DM and established CV disease. Canagliflozin has an additional indication for reducing the risk of endstage kidney disease, doubling of serum creatinine, CV death, and hospitalization for HF in adults with T2DM and diabetic nephropathy with albuminuria. None of the SGLT2 inhibitors are indicated for patients with type 1 diabetes or those with diabetic ketoacidosis. Approval of the new HF indication for dapagliflozin was based on findings from the international, multicenter,


TRENDING TOPICS continued randomized, double-blind, placebo-controlled DAPA-HF study. A total of 4,744 patients with NYHA functional class II to IV HF with a reduced left ventricular EF ≤ 40% were randomized to dapagliflozin 10 mg or placebo. At baseline, the majority of patients were receiving background therapy with 1 or more of the following agents: an angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor blocker (ARB), or angiotensin receptor-neprilysin inhibitor; a beta-blocker; a mineralocorticoid receptor antagonist; and a diuretic. At a median of 18 months, dapagliflozin was found to significantly reduce the primary composite endpoint of CV death, hospitalization for HF, or urgent HF visit by 26% compared to placebo (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.65 to 0.85; p<0.0001) with 11.6% of patients in the dapagliflozin arm experiencing an event compared to 15.6% in the placebo arm. Furthermore, all 3 components of the endpoint contributed to the observed benefit. The recommended dose of dapagliflozin for the new HF-only indication is 10 mg orally once daily.

COVID-19: NOTABLE DEVELOPMENTS As of May 11, 2020, the FDA’s Coronavirus Treatment Acceleration Program (CTAP) reports 144 active trials of potential therapeutic agents for the novel coronavirus (COVID-19) underway and an additional 457 developmental programs being planned. Furthermore, the FDA has released 2 more guidance documents for researchers to assist in efficient submission of study applications investigating potential COVID-19 therapies and provide recommendations for clinical trial design for these potential treatments. Preliminary results have been released from the National Institutes of Health (NIH)-sponsored randomized controlled trial, Adaptive COVID-19 Treatment Trial (ACTT), evaluating the investigational antiviral remdesivir in more than 1,000 hospitalized adults with advanced COVID-19 with lung involvement. Remdesivir demonstrated a statistically significant improvement compared to placebo (p<0.001) for the primary endpoint of time to recovery (defined as discharge from the hospital or hospitalization for infection-control purposes only). The largest benefit was observed in hospitalized patients with severe COVID-19 who needed supplemental oxygen;

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beneficial effects for other subgroups were less definitive. Data also suggested a mortality benefit by 14 days with the 10-day remdesivir course (7.1%) compared to placebo (11.9%), although findings for this endpoint did not reach statistical significance (HR, 0.70; 95% CI, 0.47 to 1.04). Following these early positive findings, the NIH initiated the 2nd phase of the ACTT trial (known as ACTT 2), which evaluates remdesivir alone versus remdesivir in combination with the oral anti-inflammatory drug baricitinib (Olumiant®) in more than 1,000 hospitalized adults with COVID-19. Baricitinib is a Janus kinase (JAK) inhibitor that is FDA-approved for the treatment of rheumatoid arthritis in adults. The NIH also recently initiated a trial assessing whether hydroxychloroquine in combination with azithromycin prevents hospitalization and death in adults with mild to moderate COVID-19. Genentech, the manufacturer of omalizumab (Xolair®), has announced the FDA is allowing for the temporary self-administration of the prefilled syringe (PFS) during the COVID-19 pandemic. The approved product labeling does not allow for selfadministration; however, there are challenges with administration in a healthcare setting during the pandemic, and patients with moderate to severe asthma are considered high-risk for severe COVID-19. As a result, healthcare providers (HCPs) may determine that self-administration by a patient or caregiver may be temporarily needed depending on patientspecific factors and local pandemic guidelines and/ or restrictions. Alkermes, the manufacturer of the injectable antipsychotic aripiprazole lauroxil (Aristada®) and the extended-release injectable opioid dependence treatment naltrexone (Vivitrol®), has announced additional provider locations to support expanded access to these medications during the COVID-19 pandemic. Additional alternative retail pharmacies and clinics have been added to the injection site network. For more resources on COVID-19, visit the Magellan Rx Coronavirus Update webpage. For the most current information, visit the FDA, the CDC, the NIH, and the World Health Organization (WHO) websites. State and local health departments also provide valuable information regarding management in local communities.


BEHAVIORAL HEALTH

CORNER FOCUSED UPDATE OUD TREATMENT GUIDELINES

has been unsuccessful in an OTP or office-based opioid treatment setting.

The American Society of Addiction Medicine (ASAM) released a focused update of their national practice guideline on opioid use disorder (OUD) treatment. The update provides new and revised recommendations based on recent available evidence and the incorporation of new buprenorphine formulations that received FDA approval since the release of the 2015 ASAM guidelines.

The ASAM notes that morphine milligram equivalent (MME) opioid dosing guidelines used for chronic pain are not applicable for OUD and that the opioid reversal agent naloxone should be made available to patients who are receiving treatment or who have a history of OUD. Patients and family members should receive training on how to administer naloxone in the event of an opioid overdose. Assessment of psychosocial needs, as well as referral to psychosocial treatment depending on the individual patient, are also recommended; however, if the patient declines psychosocial treatment or if it is unavailable, it should not prevent the use of pharmacotherapy.

In line with the 2015 recommendations, ASAM continues to recommend priority be given to identifying and referring urgent/emergent medical or psychiatric problems in assessing patients for OUD. A new recommendation was developed for assessing patients for OUD regarding comprehensive assessment being a key element for determining appropriate treatment; however, completing the assessments should not impede starting drug therapy for OUD. ASAM updated the assessment recommendation regarding the use of benzodiazepines and other sedativehypnotics to state that use of these agents is not a reason to withhold or suspend treatment with methadone or buprenorphine. Although concurrent use of these medications increases the potential for serious adverse effects, greater harm may result from untreated OUD. Therefore, a benefit-to-risk evaluation should be done and additional support provided to help mitigate concurrent medication-related risks. In terms of treatment, a new recommendation states there is not a set time limit for pharmacotherapy for OUD. Furthermore, all FDA-approved medications for treating OUD should be made available to patients with consideration of patient preference, past treatment history, current clinical presentation, and treatment setting to determine if methadone, buprenorphine, or naltrexone should be used. Methadone continues to be recommended for patients who may benefit from daily dosing and supervision in an opioid treatment program (OTP) and in patients for whom buprenorphine for OUD 4 | JUNE 2020

One major revision to the recommendations on managing opioid withdrawal is buprenorphine should be initiated once objective signs of opioid withdrawal are present, at which point a dose adequate to mitigate withdrawal symptoms is given (initially 2 to 4 mg titrated up as needed). Additionally, although alpha-2 adrenergic agonists (e.g., FDA-approved lofexidine [Lucemyraâ&#x201E;˘], off-label clonidine) are safe and effective for managing opioid withdrawal, ASAM notes that methadone and buprenorphine are more effective in decreasing symptoms and aiding in the completion of withdrawal. The update also provides specific recommendations on methadone, buprenorphine, and naltrexone and additional recommendations for special populations (e.g., pregnant women, patients suffering from pain, adolescents, patients with co-occurring psychiatric conditions, patients within the criminal justice system). Buprenorphine is a recommended treatment for OUD in patients who are able to give consent and do not have a contraindication. As data for the new buprenorphine formulations are limited, these agents should be used as indicated with consideration for new information as it is available.


DRUG INFORMATION

HIGHLIGHTS • Egrifta® (tesamorelin for injection) is being discontinued by the manufacturer, Theratechnologies, and will no longer be available as of June 15, 2020. It is being replaced with the new smaller volume formulation, Egrifta SV™ (tesamorelin for injection). Egrifta SV launched in December 2019 and can be stored at room temperature. • The FDA has reported Portola Pharmaceuticals will be discontinuing Bevyxxa® (betrixaban) capsules in the strengths of 40 mg and 80 mg. Bevyxxa, a factor Xa inhibitor approved in 2017, is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. • Trividia Health announced a voluntary recall of 1 True Metrix® Air Blood Glucose Meter with the serial number TA1548753 from lot KW0135 with UDI number (01)00021292006075(17)200831(10)KW0135(21) TA1548753 distributed in the US in February 2019 to AssuraMed. The recalled meter has an incorrect factory-set unit of measure, as it displays glucose results in mmol/L rather than mg/dL, potentially implying a lower result than expected if the user does not recognize the differing units of measure. This could result in a glucose level remaining high, which can lead to serious injury or impairment with risk of death. • Eli Lilly announced the launch of new authorized generic (AG) versions of Humalog ® Mix 75/25™ KwikPen® (insulin lispro protamine and insulin lispro injectable suspension, 100 units/mL) and Humalog® Junior KwikPen® (insulin lispro injection, 100 units/ mL). The AG versions will be known as Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix 75/25™ KwikPen® and Insulin Lispro Injection Junior KwikPen®, respectively.

• Fresenius Kabi USA has voluntarily recalled 13 lots of ketorolac tromethamine injection, USP, 30 mg/mL, and ketorolac tromethamine injection, USP, 60 mg/2 mL, to the user level. The recall is due to the presence of particulate matter, found in 8 reserve sample vials. Administration of products containing particulate matter could result in local irritation of blood vessels, injection-site swelling, inflamed or infected tissue mass, blood clots, scarring of lung tissues, or allergic reactions. • The American Thoracic Society (ATS) has issued guidelines on the pharmacologic management of chronic obstructive pulmonary disease (COPD). Key recommendations include (1) the use of combination therapy with a long-acting beta-adrenergic agonist (LABA) and a long-acting muscarinic antagonist (LAMA) over LABA or LAMA monotherapy for patients with COPD and dyspnea or exercise intolerance; (2) the addition of inhaled corticosteroids (ICS) for patients with dyspnea or exercise intolerance despite LABA/LAMA combination therapy and with ≥ 1 COPD exacerbation in the prior year that required antibiotics, oral steroids, or hospitalization; (3) discontinuation of an ICS in patients taking triple therapy (LABA/LAMA/ICS) if no exacerbations occurred in the past year; and (4) discouraging maintenance oral corticosteroid therapy in patients with frequent and severe exacerbations while on optimal therapy. • The FDA has granted Accelerated Approval for a new dosing regimen for the cancer agent pembrolizumab (Keytruda®), allowing for dosing of 400 mg every 6 weeks for adult patients across all currently approved indications. This new regimen is in addition to the current 200 mg every 3 weeks dosing regimen. The approval was more than 5 months before the expected FDA decision date and allows for less frequent healthcare visits for administration.


PIPELINE

NEWS

UPCOMING PRESCRIPTION DRUG/BIOSIMILAR USER FEE ACT (PDUFA/BsUFA) DATES DRUG NAME MANUFACTURER

FORMULATION THERAPEUTIC CLASS

PROPOSED CLINICAL USE

ANTICIPATED FDA APPROVAL

abicipar pegol Allergan

• intraocular • vascular endothelial growth factor (VEGF) inhibitor

Wet age-related macular degeneration

Jun-Jul 2020

inebilizumab Viela Bio

• IV • anti-CD19 monoclonal antibody

Atherosclerosis in patients with T2DM

Jun-Jul 2020

relebactam/imipenem/ cilastatin (Recarbrio®) Merck

• IV • beta-lactam antibiotic/ dehydropeptidase inhibitor/ beta-lactamase inhibitor

Healthcare-acquired pneumonia

June 4, 2020

pembrolizumab (Keytruda®) Merck

• IV • programmed cell death 1 (PD-1) inhibitor

Solid tumors (tissue tumor mutational burden-high);

June 16, 2020

Cutaneous squamous cell carcinoma

June 29, 2020

burosumab-twza (Crysvita®) Ultragenyx

• SC • fibroblast growth factor inhibitor

Osteomalacia (tumor-induced)

June 18, 2020

tazemetostat (Tazverik®) Epizyme

• oral • enhancer of zeste homolog 2 (EZH2) inhibitor

Follicular lymphoma

June 18, 2020

selinexor (Xpovio) Karyopharm

• oral • nuclear export inhibitor

Diffuse large B-cell lymphoma

June 23, 2020

fenfluramine (low dose) Zogenix

• oral • serotonin reuptake inhibitor

Dravet syndrome

June 25, 2020

evinacumab Regeneron

• SC • anti-angiopoietin-like protein 3 (ANGPTL3) monoclonal antibody

Dyslipidemia

July 1, 2020

IV = intravenous; SC = subcutaneous

6 | JUNE 2020


RECENT FDA

APPROVALS DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs monomethyl fumarate (Bafiertam™) Banner

• 505(b)(2) NDA approval 04/28/2020 • Indicated for the treatment of adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease • Oral fumarate that is bioequivalent to dimethyl fumarate (Tecfidera®) • Delayed-release capsule: 95 mg • Recommended starting dosage is 95 mg orally twice a day for 7 days, followed by maintenance dosing of 190 mg (two 95 mg capsules) twice a day with or without food • Product availability is expected soon

progesterone vaginal system (Milprosa™) Ferring

• 505(b)(2) NDA approval 04/29/2020 • Indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an assisted reproductive technology treatment program for infertile women ≤ 34 years of age; efficacy in women ≥ 35 years of age has not been established • Progesterone • Vaginal system: 1.78 grams of progesterone in a flexible, non-biodegradable silicone ring • Recommended dosage is 1 vaginal system inserted the day after oocyte retrieval then replaced weekly for a total of up to 10 weeks

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs continued daratumumab and hyaluronidase-fihj (Darzalex Faspro™) Janssen

• BLA approval 05/01/2020; Assessment Aid, Orphan Drug • Indicated for adults with multiple myeloma: » In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT) » In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received ≥ 1 prior therapy » In combination with bortezomib and dexamethasone in patients who have received ≥ 1 prior therapy » As monotherapy, in patients who have received ≥ 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are doublerefractory to a PI and an immunomodulatory agent • CD38-directed cytolytic antibody and an endoglycosidase • Injection: 1,800 mg daratumumab and 30,000 units hyaluronidase per 15 mL of solution in a single-dose vial (SDV) • Recommended dosage is 1,800 mg/30,000 units administered subcutaneously (SC) into the abdomen over 3 to 5 minutes according to the recommended schedule described in the prescribing information as monotherapy or part of combination therapy; administer pre-medications (long- or intermediate-acting corticosteroid, acetaminophen, and a histamine-1 receptor antagonist) 1 to 3 hours prior to each dose and post-medications dependent on if used as monotherapy or in combination with other agents

leuprolide acetate (Fensolvi®) Tolmar

• 505(b)(2) NDA approval 05/01/2020 • Indicated for the treatment of pediatric patients ≥ 2 years of age with central precocious puberty • Gonadotropin releasing hormone (GnRH) agonist • Injection: kit for reconstitution resulting in final concentration of 45 mg/0.375 mL • Recommended dosage is 45 mg administered by an HCP via SC injection every 6 months

celecoxib (Elyxyb™) Dr. Reddy’s

• 505(b)(2) NDA approval 05/05/2020 • Indicated for acute treatment of migraine with or without aura in adults; it is not indicated for preventive treatment of migraine • Nonsteroidal anti-inflammatory drug (NSAID) • Oral solution: 120 mg/4.8 mL • Recommended dosage is 120 mg orally with or without food; do not exceed 120 mg in a 24-hour period • Boxed warning for serious CV and gastrointestinal events

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.

8 | JUNE 2020


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

New Drugs continued capmatinib (Tabrecta™) Novartis

• NDA approval 05/06/2020; Accelerated Approval, Breakthrough Therapy, Priority Review, Orphan Drug • Indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test; continued approval for this indication may require demonstration of benefit in confirmatory clinical trials • Kinase inhibitor • Tablet: 150 mg and 200 mg • Recommended dosage is 400 mg orally twice daily with or without food

selpercatinib (Retevmo™) Loxo Oncology

• NDA approval 05/08/2020; Accelerated Approval, Breakthrough Therapy, Priority Review, Orphan Drug • Indicated for the treatment of: » Adults with metastatic rearranged during transfection (RET) fusion-positive NSCLC » Patients ≥ 12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy » Patients ≥ 12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) » Continued approval for these indications may require demonstration of benefit in confirmatory clinical trials • Kinase inhibitor • Capsule: 40 mg and 80 mg • Recommended dosage is 120 mg orally twice daily in patients < 50 kg and 160 mg orally twice daily in patients ≥ 50 kg

ripretinib (Qinlock™) Deciphera

• NDA approval 05/15/2020; Breakthrough Therapy, Fast Track, Orphan Drug, Priority Review, Project Orbis, Real-Time Oncology Review (RTOR) • Indicated for treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with ≥ 3 kinase inhibitors, including imatinib • KIT proto-oncogene receptor tyrosine kinase (KIT) and platelet derived growth factor A (PDGFRA) kinase inhibitor • Tablet: 50 mg • Recommended dosage is 150 mg orally once daily with or without food

Expanded Indications efinaconazole (Jublia®) Bausch

• sNDA approval 04/26/2020 • Expanded indication to include patients ≥ 6 years of age for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes » Previously approved in adults only • Recommended dosage for all patients is to apply to affected toenail(s) once daily for 48 weeks

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

Expanded Indications continued pembrolizumab (Keytruda®) Merck

• sBLA approval 04/28/2020; Accelerated Approval • Alternate dosing schedule for all approved indications for adults: melanoma, classical Hodgkin lymphoma, primary mediastinal B-cell lymphoma, hepatocellular carcinoma, Merkel cell carcinoma, gastric cancer, NSCLC, renal cell carcinoma, endometrial carcinoma, cervical cancer, urothelial carcinoma, head and neck squamous cell cancer, small cell lung cancer, esophageal cancer, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors; continued approval for these indications may require demonstration of benefit in confirmatory clinical trials • Alternate dosing schedule is 400 mg administered intravenously (IV) every 6 weeks; already approved as 200 mg IV every 3 weeks dosing regimen

niraparib (Zejula®) GlaxoSmithKline

• sNDA approval 04/29/2020; Assessment Aid; RTOR • New indication for maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to 1st-line platinum-based chemotherapy » Also approved for other select patients with ovarian, fallopian tube, or primary peritoneal cancer • Recommended dosage for patients weighing < 77 kg or with a platelet count of < 150,000/μL is 200 mg orally once daily; for patients weighing ≥ 77 kg and who have a platelet count ≥ 150,000/μL, the recommended dosage is 300 mg orally once daily

olaparib tablets (Lynparza®) AstraZeneca

• sNDA 05/8/2020; Assessment Aid • New indication for use in combination with bevacizumab for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability » Also approved for use in select ovarian cancer, breast cancer, and pancreatic cancer patients • Recommended dosage is 300 mg orally twice daily, with or without food, until disease progression, unacceptable toxicity, or completion of 2 years of treatment

pomalidomide (Pomalyst®) Celgene

• sNDA 05/14/2020; Accelerated Approval, Breakthrough Therapy, Orphan Drug • New indication for the treatment of adults with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are human immunodeficiency virus (HIV)-negative; continued approval for this indication may require demonstration of benefit in confirmatory clinical trials • Recommended dosage for KS is 5 mg daily taken orally on days 1 through 21 of repeated 28-day cycles until disease progression or unacceptable toxicity

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant.

10 | JUNE 2020


RECENT FDA APPROVALS continued DRUG NAME MANUFACTURER

DESCRIPTION

Expanded Indications continued nivolumab plus ipilimumab (Opdivo®, Yervoy®) Bristol Myers Squibb

• sNDA 05/15/2020; Priority Review • New indication for combination therapy as 1st-line treatment for patients with metastatic NSCLC whose tumors express programmed death ligand 1 (PD-L1) ≥ 1%, as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations » Also approved for use in select patients with metastatic NSCLC with progression on or after platinum-based chemotherapy as well as for other select cancer patients • Recommended dosage is nivolumab 3 mg/kg IV every 2 weeks and ipilimumab 1 mg/kg IV every 6 weeks until disease progression, unacceptable toxicity, or completion of 2 years of treatment in patients without disease progression

rucaparib (Rubraca®) Clovis Oncology

• sNDA 05/15/2020; Accelerated Approval, Breakthrough Therapy, Priority Review • New indication for treatment of adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy; continued approval for this indication may require demonstration of benefit in confirmatory clinical trials » Also approved for use in select patients with ovarian cancer • Recommended dosage is 600 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity; patients should also receive a GnRH analog or should have had a bilateral orchiectomy

atezolizumab (Tecentriq®) Genentech

• sBLA 05/18/2020; Assessment Aid, Priority Review • Expanded indication for 1st-line treatment of adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥ 10% of the tumor area), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations » Also approved for use in other select NSCLC patients as well as in select urothelial carcinoma, triple-negative breast cancer (TNBC), and small cell lung cancer (SCLC) patients • Recommended dosage is 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks, administered IV over 60 minutes

olaparib tablet (Lynparza®) AstraZeneca

• sNDA 05/19/2020; Assessment Aid, Breakthrough Therapy, Priority Review • New indication for the treatment of adults with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone; patients should be selected for treatment based on an FDA-approved companion diagnostic » Also approved for use in select ovarian cancer, breast cancer, and pancreatic cancer patients • Recommended dosage is 300 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity; patients should also receive a GnRH analog or should have had a bilateral orchiectomy

ANDA = Abbreviated New Drug Application; BLA = Biologics License Application; H = Half; NDA = New Drug Application; Q = Quarter; sBLA = Supplemental Biologics License Application; sNDA = Supplemental New Drug Application; 505(b)(2) = FDA approval pathway that allows for submission of data from studies not conducted by or for the applicant. References:

asam.org

fda.gov

icer.org

nejm.org

nih.gov

thoracic.org

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