Drugs

BMS Gets Liso-cel Approval for Lymphoma

Bristol-Myers Squibb 2/5 won BLA approval for (Breyanzi) lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The BLA’s review was put on hold in November pending the completion of an inspection, which was delayed due to the Covid-19 pandemic, at third-party manufacturer Lonza.

Last month, BMS said the inspection of the Lonza manufacturing plant took place from 12/3 to 12/10/2020 and that both firms “expeditiously responded to observations received at the close of the inspection within eight days.” Additionally, “BMS received information requests which were also rapidly responded to and there are currently no outstanding information requests at this time,” the statement said. Late last year, BMS was also hit with a related six-observation FDA-483 (see story) after an inspection at Juno Therapeutics, Bothell, WA, which the company controls after its acquisition of Celgene.

In announcing the approval, FDA says each dose of Breyanzi is a customized treatment created using a patient’s own T-cells. “The patient’s T-cells are collected and genetically modified to include a new gene that facilitates targeting and killing of the lymphoma cells,” it says. “Once the cells are modified, they are infused back into the patient.”

Approval was based on data from about 250 adults with refractory or relapsed large B-cell lymphoma. The complete remission rate after treatment was 54%, FDA says. The therapy’s labeling carries a Boxed Warning for cytokine release syndrome, a systemic response to the activation and proliferation of CAR T cells, which causes high fever, flu-like symptoms and neurologic toxicities, it says.

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

Read more

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