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Weekly Drug News Round-Up: May 18, 2016

FDA Approves Genentech’s First-in-Class Tecentriq to Target Bladder Cancer

Tecentriq is the first PD-L1 inhibitor approved by the FDA Read More…

Today the US Food and Drug Administration (FDA) approved Genentech’s Tecentriq (atezolizumab) to treat urothelial carcinoma, a common bladder cancer. The FDA also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels. Tecentriq is the first FDA-approved PD-L1 inhibitor and the latest in the broader class of PD-1/PD-L1 targeted biologics approved by the FDA in the last two years. In studies, 14.8% of patients had at least partial shrinkage of tumors lasting 2.1 to over 13.8 months at the time of analysis. Approved anti-PD-1 drugs include Merck's Keytruda (pembrolizumab) and BMS's Opdivo (nivolumab).

FDA Clears Bristol-Myers Squibb’s Opdivo for Classical Hodgkin Lymphoma

Roughly 8,500 new cases of Hodgkin Lymphoma are predicted to be diagnosed in 2016 Read More…

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody for the treatment of advanced melanoma, advanced non-small cell lung cancer, and advanced renal cell carcinoma. This week, FDA approved a new use for Opdivo for patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin (Adcetris). From the CheckMate-205 and -039 clinical studies, a 7% complete response rate and a 58% partial response rate occurred, with a median response time of 2.1 months. Among responders, Opdivo demonstrated an 8.7 month median duration of response.

FDA Approves Eisai’s Lenvima For Advanced Kidney Cell Cancer

Lenvima was previously approved in February 2015 to treat progressive thyroid cancer Read More...

Lenvima (lenvatinib) is an oral multiple receptor tyrosine kinase (RTK) inhibitor that blocks certain proteins that boost cancer cell growth. Last week the FDA approved Lenvima for treatment of advanced renal cell carcinoma (kidney cancer) in combination with everolimus in patients who were previously treated with an anti-angiogenic therapy. In the Phase II Study 205, Lenvima and everolimus together resulted in a median progression-free survival (PFS) nearly three times that of everolimus alone. The median PFS, the length of time from study entry until disease progression or death, was 14.6 months for the combined treatment compared with 5.5 months with everolimus alone.

FDA Investigating Link Between Common Diabetes Drug and Amputations

Health care providers should continue to follow the recommendations in the canagliflozin drug labels Read More...

Canagliflozin, found in the prescription drugs Invokana and Invokamet, is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Today, the FDA is alerting the public about interim safety results from a study that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with canagliflozin. FDA has not determined whether canagliflozin increases the risk of leg and foot amputations, and will update the public when more information is available. Patients should not stop or change their diabetes medicines without first talking to their health care professional.

FDA: Restrict Fluoroquinolone Use For More Complicated Infections

FDA is requiring label updates to reflect this new safety information Read More...

An FDA safety review has shown that the class of antibiotic drugs known as fluoroquinolones are associated with multiple serious side effects with systemic use, such as with tablets, capsules, or injections. Fluoroquinolones include medicines such as ciprofloxacin (Cipro), levofloxacin (Levaquin), and moxifloxacin (Avelox). Side effects can involve tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations and should be reported immediately to a healthcare provider. FDA is advising that the risks outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.

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