Drugs

FDA Approves New Indication for Merck’s Keytruda

FDA has approved Merck’s Keytruda (pembrolizumab) for intravenous injection for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The agency says it is the first immunotherapy approved for this patient population as a first-line treatment that is administered to patients without also giving chemotherapy. Keytruda was previously approved by FDA for treating other types of cancer.

Keytruda reportedly works by targeting the cellular pathway of proteins found on the body’s immune cells and some cancer cells. FDA says that by blocking the pathway, Keytruda may help the body’s immune system fight the cancer cells and provide a benefit for patients with the cancers listed in the indication.

The approval was based on the results of one multicenter, international, open-label, active-controlled trial that compared Keytruda with chemotherapy treatment in 307 patients with the listed colorectal cancers. The study reportedly demonstrated a statistically significant improvement in progression-free survival.

The application received priority review and also used the real-time oncology review program, the assessment aid, and summary level review. FDA says it collaborated with international agency counterparts on the application review under Project Orbis.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome