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e-Newsletter : May 2020

Tabrecta is First Approval for Non-Small Cell Lung Cancer with MET Exon 14 Skipping

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer.

  1. In May, the U.S. Food and Drug Administration (FDA) approved Novartis’ Tabrecta (capmatinib) for the treatment of adult patients with metastatic NSCLC with specific mutations (MET exon 14 skipping). About 3% to 4% of patients with metastatic NSCLC have this mutation (4,000 to 5,000 U.S. patients each year).

  2. Tabrecta is classified as a kinase inhibitor that targets MET and is approved for first-line therapy. It is given as a 400 mg oral tablet twice daily with or without food.

  3. In the Phase 2 GEOMETRY mono-1 study, the overall response rate (ORR) for 28 participants who had never received treatment was 68%, with 47% of patients having a duration of response lasting 12 months or longer.

  4. Common side effects include leg swelling, nausea, fatigue, vomiting, shortness of breath and decreased appetite.

FDA Approves Qinlock for Fourth-Line Treatment of Gastrointestinal Stromal Tumor (GIST)

Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract most often occurring in the stomach or small intestine.

  1. This month, the FDA approved Qinlock (ripretinib) for the treatment of adults with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

  2. Qinlock, from Deciphera Pharmaceuticals, is a broad-spectrum KIT and PDGFRα inhibitor that targets mutations known to drive GIST. It comes as an oral tablet taken once daily.

  3. In the Phase 3 INVICTUS study, Qinlock demonstrated a median progression-free survival (PFS) of 6.3 months compared to 1 month in the placebo (inactive) group. Risk of disease progression or death was reduced by 85%.

  4. Common side effects (≥20%) included hair loss, fatigue, nausea, stomach pain, constipation, muscle aches, vomiting and diarrhea, among others. 

Retevmo is First Therapy Approved for Cancer Patients with RET Gene Alterations

The FDA has cleared Eli Lilly’s Retevmo (selpercatinib), a selective RET kinase inhibitor used to treat: non-small cell lung cancer, medullary thyroid cancer and other thyroid cancers in patients with advanced or metastatic RET (rearranged during transfection)-driven tumors.

  1. Retevmo is a kinase inhibitor and blocks an enzyme to slow cancer growth. It comes as an oral capsule given twice daily. Patients are selected for treatment based on a specific biomarker test.

  2. The Phase 1/2 LIBRETTO-001 trial enrolled both treatment-naive patients and heavily pretreated patients across tumor types. Overall response rates (ORR) ranged from 69% to 100% among the groups. The median duration of response (DoR) lasting at least six months ranged from 58% to 87% of patients.

  3. Serious adverse reactions occurred in 33% of patients who received Retevmo, including liver damage, elevated blood pressure, heart rhythm disorders, bleeding and allergic reactions.

Darzalex Faspro Offers a Rapid Administration Time in Multiple Myeloma

In May, the FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) from Janssen Pharmaceuticals, a new subcutaneous formulation of daratumumab for treatment of multiple myeloma. Multiple myeloma is an incurable blood cancer that forms in the bone marrow. 

  1. Darzalex Faspro is approved for patients with newly diagnosed, relapsed or refractory multiple myeloma in combination with other treatments or as monotherapy, depending upon indication.

  2. Darzalex Faspro, a CD38-directed antibody, is administered subcutaneously into the abdomen over 3 to 5 minutes, significantly less time than intravenous (IV) Darzalex which takes several hours or longer.

  3. In the Phase 3 COLUMBA study, Darzalex Faspro demonstrated a consistent overall response rate and similar safety profile, including a reduction in systemic administration-related reactions when compared to IV Darzalex, (13% vs. 34%, respectively).

  4. The most common adverse reaction (≥20%) with monotherapy is upper respiratory tract infections. 

New Drug Approvals

Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) Capsules

Company: AbbVie Inc. Date of Approval: May 29, 2020 Treatment for: Uterine Leiomyomata

Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist, estrogen and progestin co-formulation indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Tauvid (flortaucipir F 18) Injection

Company: Eli Lilly and Company Date of Approval: May 28, 2020 Treatment for: Diagnostic

Tauvid (flortaucipir F 18) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).

Zilxi (minocycline) Topical Foam – formerly FMX103

Company: Foamix Pharmaceuticals Ltd. Date of Approval: May 28, 2020 Treatment for: Acne Rosacea

Zilxi (minocycline) is a topical tetracycline formulation indicated for the treatment of inflammatory lesions of rosacea in adults.

artesunate for Injection

Company: Amivas (US), LLC Date of Approval: May 26, 2020 Treatment for: Malaria

Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients.

Phexxi (lactic acid, citric acid and potassium bitartrate) Vaginal Gel – formerly Amphora

Company: Evofem, Inc. Date of Approval: May 22, 2020 Treatment for: Contraception

Phexxi (lactic acid, citric acid and potassium bitartrate) is a non-hormonal vaginal gel indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Kynmobi (apomorphine hydrochloride) Sublingual Film

Company: Sunovion Pharmaceuticals Inc. Date of Approval: May 21, 2020 Treatment for: Parkinson’s Disease

Kynmobi (apomorphine sublingual film) is a novel formulation of the approved dopamine agonist apomorphine for the on-demand management of OFF episodes associated with Parkinson’s disease (PD).

Cerianna (fluoroestradiol F18) Injection

Company: Zionexa USA Date of Approval: May 20, 2020 Treatment for: Diagnostic

Cerianna (fluoroestradiol F18) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

Qinlock (ripretinib) Tablets

Company: Deciphera Pharmaceuticals, Inc. Date of Approval: May 15, 2020 Treatment for: Gastrointestinal Stromal Tumor

Qinlock (ripretinib) is a broad-spectrum KIT and PDGFRα inhibitor for the treatment of patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Retevmo (selpercatinib) Capsules

Company: Eli Lilly and Company Date of Approval: May 8, 2020 Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer

Retevmo (selpercatinib) is a kinase inhibitor for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

Tabrecta (capmatinib) Tablets

Company: Novartis Pharmaceuticals Corporation Date of Approval: May 6, 2020 Treatment for: Non-Small Cell Lung Cancer

Tabrecta (capmatinib) is a kinase inhibitor indicated for the treatment of adult patients 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.

Elyxyb (celecoxib) Oral Solution

Company: Dr. Reddy’s Laboratories, Inc. Date of Approval: May 5, 2020 Treatment for: Migraine

Elyxyb (celecoxib) is an oral solution formulation of the nonsteroidal anti-inflammatory drug celecoxib (first approved under the brand name Celebrex) indicated for the acute treatment of migraine with or without aura in adults.

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Injection

Company: Janssen Pharmaceuticals, Inc. Date of Approval: May 1, 2020 Treatment for: Multiple Myeloma

Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase indicated for the treatment of adult patients with multiple myeloma.

Fensolvi (leuprolide acetate) Injection

Company: Tolmar Pharmaceuticals, Inc. Date of Approval: May 1, 2020 Treatment for: Precocious Puberty

Fensolvi (leuprolide acetate) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

New Indications and Dosage Forms

Brilinta (ticagrelor) Tablets

New Indication Approved: May 28, 2020 Date of Original Approval: July 20, 2011

Brilinta (ticagrelor) is a P2Y12 platelet inhibitor indicated:

  1. to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Brilinta also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.

  2. to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of Brilinta was established in a population with type 2 diabetes mellitus (T2DM).

Sirturo (bedaquiline) Tablets

New Formulation Approved: May 27, 2020 Date of Original Approval: December 28, 2012

Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug indicated for the treatment of pulmonary multi-drug resistant tuberculosis.

VESIcare (solifenacin succinate) Tablets

New Dosage Form Approved: May 26, 2020 Date of Original Approval: November 19, 2004

VESIcare (solifenacin) is a muscarinic receptor antagonist for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. VESIcare LS is an oral suspension formulation of solifenacin for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.

Dupixent (dupilumab) Injection

Patient Population Altered: May 26, 2020 Date of Original Approval: March 28, 2017

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated:

  1. for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

  2. as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: Not for the relief of acute bronchospasm or status asthmaticus.

  3. as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

Alunbrig (brigatinib) Tablets

New Indication Approved: May 22, 2020 Date of Original Approval: April 28, 2017

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Lynparza (olaparib) Tablets

New Indication Approved: May 19, 2020 Date of Original Approval: December 19, 2014

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

Ferriprox (deferiprone) Tablets and Oral Solution

New Formulation Approved: May 19, 2020 Date of Original Approval: October 14, 2011

Ferriprox (deferiprone) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

Tecentriq (atezolizumab) Injection

New Indication Approved: May 18, 2020 Date of Original Approval: May 18, 2016

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and small cell lung cancer (SCLC).

Rubraca (rucaparib) Tablets

New Indication Approved: May 15, 2020 Date of Original Approval: December 19, 2016

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of ovarian cancer and prostate cancer.

Opdivo (nivolumab) Injection

New Indication Approved: May 15, 2020 Date of Original Approval: December 22, 2014

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

Pomalyst (pomalidomide) Capsules

New Indication Approved: May 14, 2020 Date of Original Approval: February 8, 2013

Pomalyst (pomalidomide) is a thalidomide analogue indicated for the treatment of patients with multiple myeloma and AIDS-related and HIV-negative Kaposi sarcoma.

Lynparza (olaparib) Tablets

New Indication Approved: May 8, 2020 Date of Original Approval: December 19, 2014

Lynparza (olaparib) is a first-in-class oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.

Farxiga (dapagliflozin) Tablets

New Indication Approved: May 5, 2020 Date of Original Approval: January 8, 2014

Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for the treatment of type 2 diabetes mellitus and heart failure.

First-Time Generic Approvals May 2020

Ivermectin Lotion 0.5% Approved: May 6, 2020 – Taro Pharmaceuticals U.S.A., Inc. Generic for: Sklice Desonide Topical Gel 0.05% Approved: May 11, 2020 – Teresina Holdings LLC Generic for: Desonate Gel Calcipotriene and Betamethasone Dipropionate Topical Suspension 0.005% / 0.064% Approved: May 11, 2020 – Tolmar Pharmaceuticals Inc. Generic for: Taclonex Scalp Posaconazole Oral Suspension 40mg/ mL Approved: May 15, 2020 – Hikma Pharmaceuticals USA Inc. Generic for: Noxafil Oral Suspension Icosapent Ethyl Capsules 1 gm Approved: May 21, 2020 – Hikma Pharmaceuticals USA Inc. Generic for: Vascepa

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