Monthly News Roundup – October 2016

Merck’s Zinplava Approved to Fend Off Return of Clostridium Difficile

Zinplava (bezlotoxumab) has been FDA-approved to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for CDI and who are at high risk for CDI recurrence. Zinplava is not an antibacterial and does not treat an active CDI infection. Zinplava is a human monoclonal antibody that binds with C. difficile toxin B to prevent its effects on human cells. Common adverse reactions include nausea, pyrexia and headache. Heart failure, a serious adverse reaction, was noted in 2.3% of Zinplava-treated patients and 1.0% of placebo-treated patients.

Lilly’s Lartruvo Gains Accelerated Approval for Soft Tissue Sarcoma

The FDA has granted accelerated approval to Lartruvo(olaratumab) to be used with the chemotherapy drug doxorubicin for treatment of patients with soft tissue sarcoma(STS) who cannot be cured with radiation or surgery. Lartruvo acts as a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody to help slow or stop tumor growth. In clinical trials, patients who received Lartruvo with doxorubicin had a statistically significant improvement in overall survival: the median survival was 26.5 months compared to 14.7 months for patients who received doxorubicin alone. Common side effects included nausea, fatigue, low white blood cells (neutropenia), and muscle pain, among others.

Keytruda Now First-Line for Advanced Non-Small Cell Lung Cancer

Merck’s anti-PD-1 (programmed death receptor-1) therapy Keytruda (pembrolizumab) has been approved for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR/ALK tumor abnormalities. Based on KEYNOTE-024 interim data, Keytruda reduced disease progression or death by 50 percent compared to chemotherapy. Keytruda is now the only anti-PD-1 therapy approved first-line treatment for this patient population. The trial was stopped early so patients on chemotherapy could receive Keytruda. Immune-mediated side effects include inflammation of the lungs, colon, liver, kidney and endocrine gland problems.

Genentech’s Tecentriq Approved to Treat Advanced Form of Lung Cancer

Tecentriq (atezolizumab), an immunotherapy agent used in cancer, has been approved to treat metastatic non-small cell lung cancer (NSCLC) with EGFR/ALK gene abnormalities, in patients whose disease has progressed during or after treatment with a platinum-based chemotherapy or other appropriate targeted therapy. Patients were enrolled in studies regardless of their PD-L1 status. In clinical studies, patients receiving Tecentriq lived a median 4.2 months longer than patients receiving chemotherapy with docetaxel (13.8 vs. 9.6 months). Possible side effects with Tecentriq include lung inflammation, hepatitis, intestinal inflammation, hormone gland problems, eye inflammation, and severe infections and infusion reactions.

Carnexiv Approved as First Injectable Carbamazepine

The U.S. Food and Drug Administration has approved Lundbeck’s Carnexiv (carbamazepine), an intravenous (IV) injection formulation of the antiepileptic drug carbamazepine. Carnexiv is indicated as short-term (≤7 days) replacement therapy for oral carbamazepine when oral administration for certain seizures in adults is temporarily not feasible. Carnexiv will be the first available IV formulation of carbamazepine. The total daily dosage of Carnexiv is 70% of the total daily oral dose divided equally into four separate 30-minute infusions separated by 6 hours. Carnexiv should be on the U.S. market by early 2017.