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Monthly News Roundup - 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.

  • 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).
  • 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.
  • 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.
  • 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.

  • 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.
  • 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.
  • 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%.
  • 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.

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

FDA Approves Elyxyb Oral Solution For Acute Migraine Headaches

The FDA has approved the nonsteroidal anti-inflammatory drug (NSAID) Elyxyb (celecoxib oral solution 25 mg/mL) from Dr. Reddy’s Laboratories for the acute treatment of migraine with or without aura in adults.

  • Elyxyb solution is formulated using a specialized emulsifying delivery system to improve absorption, allowing for a lower dose.
  • In pivotal studies, Elyxyb had a rapid onset of action which is beneficial for treating acute migraine attacks. The recommended dose of Elyxyb is 120 mg taken orally with or without food. 
  • The most common side effect is altered taste. Like other NSAIDs, Elyxyb carries a Boxed Warning for increased risk of serious cardiovascular and gastrointestinal side effects.
  • Celecoxib is also available in the U.S. in capsule form as the brand name product Celebrex, as well as a generic option.

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. 

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

Posted: May 2020