Drugs

AstraZeneca’s Calquence Wins Traditional Approval

FDA has granted AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. Traditional approval was also granted for acalabrutinib’s use as a single agent for adults with previously treated MCL. Acalabrutinib originally received accelerated approval in 2017.

Traditional approval was based on data from the ECHO (NCT02972840) multicenter trial in 598 patients with untreated MCL who were randomized (1:1) to receive acalabrutinib plus bendamustine and rituximab (acalabrutinib plus BR) or placebo plus BR, an agency release says. Progression-free survival (PFS) was “significantly longer” in the acalabrutinib arm, it says, adding that median PFS was 66.4 months in the acalabrutinib plus BR arm and 49.6 months in the placebo plus BR arm.

Regarding serious adverse reactions, FDA says 69% of patients with acalabrutinib plus BR experienced serious adverse reactions, and fatal adverse reactions occurred in 12% of treated patients.

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