Drugs

FDA Priority Review for Boehringer Gilotrif sNDA

In its fourth major decision since May for drug products aimed at non-small cell lung cancer (NSCLC), FDA has accepted for priority review a Boehringer Ingelheim supplemental NDA for Gilotrif (afatinib) that seeks an indication for first-line treatment of certain patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an agency-approved test. The other three decisions involved AstraZeneca’s Tagrisso (osimertinib) and Imfinzi (durvalumab), and Novartis’ Zykadia (ceritinib).

Gilotrif is already approved for first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, and squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. The submission is based on a meta-analysis of three clinical trials from the LUX-Lung clinical trial program that examined the efficacy of Gilotrif in patients whose tumors have uncommon EGFR mutations. The company says that the efficacy outcomes evaluated in the study included: objective response, disease control, duration of response, progression-free survival and overall survival.

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