FDA Monthly News Roundup


FDA Approves Lilly’s Verzenio: Targeted Breast Cancer Treatment

Lilly’s Verzenio (abemaciclib), a CDK 4/6 inhibitor breast cancer treatment, has been FDA-approved. Verzenio is used in 2 patient populations: either with fulvestrant (Faslodex) in patients with HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy; or as monotherapy for patients who previously received endocrine therapy and chemotherapy. In combination with fulvestrant, the median progression-free survival was 16.4 months compared to 9.3 months for the fulvestrant/placebo group. In monotherapy trials, 19.7% of patients taking Verzenio experienced complete or partial shrinkage of their tumors for a median 8.6 months. Palbociclib (Ibrance) and ribociclib (Kisqali) are other kinase inhibitors approved for metastatic breast cancer.

Trelegy Ellipta: First Once-Daily, Triple Therapy Inhaler for COPD

Chronic obstructive pulmonary disease (COPD) is a common but serious lung disease that is thought to affect 384 million people worldwide. GSK’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is the first dry powder inhaled corticosteroid, long-acting muscarinic antagonist (LAMA) and long-acting beta2-adrenergic agonist (LABA) combination approved for the treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is indicated for either those on a fixed-dose combination of fluticasone/vilanterol (Breo Ellipta) who need additional bronchodilation, or those who are already using Breo Ellipta and Incruse Ellipta.

Solosec Approved as Single Dose Therapy for Bacterial Vaginosis

The U.S. Food and Drug Administration (FDA) has approved Symbiomix’s Solosec (secnidazole) 2 gram (g) oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec, a nitroimidazole antibiotic, is the only single dose oral therapy for BV. The FDA approval included two pivotal trials in BV and an open label safety study which found efficacy for single-dose secnidazole. All treatment-emergent adverse events were mild or moderate in intensity; no serious adverse events were reported and no patients discontinued treatment due to adverse events. Solosec will be available commercially in the first quarter of 2018.

FDA Clears Bayer’s Aliqopa for Relapsed Follicular Lymphoma

Follicular lymphoma is a slow-growing type of B-cell non-Hodgkin lymphoma, a cancer of the lymph system. This week, the FDA approved Aliqopa (copanlisib), a phosphatidylinositol-3-kinase (PI3K) inhibitor (kinase inhibitor) indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least 2 prior treatments. Aliqopa works by blocking several enzymes that promote cell growth. In a single-arm study with 104 patients, 59% of patients had a complete or partial response for a median 12.2 months. Common side effects of Aliqopa include high blood sugar levels, diarrhea, decreased energy, and high blood pressure, among others.

FDA Approves Mvasi: The First Cancer Biosimilar

The first biosimilar to treat cancer – Amgen’s Mvasi (bevacizumab-awwb) – has been approved by the U.S. Food and Drug Administration (FDA). Mvasi is a biosimilar to Genentech’s Avastin (bevacizumab), and is indicated for multiple types of cancer, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, brain cancer (glioblastoma), metastatic renal cell carcinoma (kidney cancer) and cervical cancer. Approval of Mvasi is based on review of safety and effectiveness data that show Mvasi is highly similar to Avastin, but it is not an interchangeable biosimilar. Common side effects of Mvasi include nosebleeds, headache, high blood pressure, and nasal inflammation, among others.
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