Drugs

FDA Safety Concern on Glaxo Myeloma BLA

FDA reviewers are raising safety concerns about a GlaxoSmithKline BLA for belantamab mafodotin which heads to an Oncologic Drugs Advisory Committee meeting 7/14 for the proposed indication for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

An FDA briefing document says the drug offers an important treatment option to address a high unmet medical need. “The deep responses achieved in approximately one-third of patients treated with belantamab mafodotin, with a [duration of response] longer than the expected [overall survival] in this patient population, provides an unprecedented benefit over currently approved agent in this heavily pre-treated relapsed refractory multiple myeloma patient,” it says. The benefit is balanced with its safety profile comprised of corneal and hematologic events, it continues, which require careful management but largely resolve over time, and allow patients to maintain their quality of life while they “avoid clinical deterioration due to myeloma progression.”

FDA says that the ocular toxicity associated with treatment with belantamab mafodotin is a major safety concern. “The mechanism is not completely understood, and this is a novel toxicity that is not typically seen with other anti-myeloma therapies,” the briefing document says. “The incidence and severity of keratopathy observed in DREAMM-2 was high and associated with clinically relevant decreases in visual acuity, including severe vision loss in some patients, and significant interference with patients’ activities of daily living and impacts on driving and reading. Dose modifications, including dose interruption, dose reduction, and discontinuation of study treatment, are the primary mitigation strategy for the ocular toxicity observed with belantamab mafodotin.”

To address the safety concern, Glaxo is proposing a comprehensive Risk Evaluation and Mitigation Strategy that includes ophthalmic examinations prior to each cycle, and promptly for worsening symptoms, to ensure that patients are examined prior to each dose.

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