Drugs

Bayer Withdrawing Aliqopa After Failed Study

Bayer is withdrawing its NDA for Aliqopa (copanlisib) for adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. The decision follows discussions with FDA about a failed confirmatory study that was required to confirm the therapy’s clinical benefit, according to the company.

Aliqopa was granted accelerated approval in 2017 based on CHRONOS-1, an open-label, single-arm Phase II study. Bayer subsequently initiated the confirmatory study (CHRONOS-4) that evaluated the addition of Aliqopa to standard immunochemotherapy regimens, but it did not meet the primary endpoint of progression-free survival benefit versus the standard immunochemotherapy control arm in patients with relapsed follicular lymphoma, according to the company. Bayer intends to publish the results of CHRONOS-4 shortly.

Bayer says it is “exploring access options for patients currently receiving Aliqopa who have experienced a favorable response to treatment, whose treating physician supports continuing treatment with Aliqopa, and for whom there may be no suitable alternative treatments available.”

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