Biologics

Iovance Biotherapeutics BLA for Melanoma Therapy

Iovance Biotherapeutics has begun a rolling BLA for lifileucel, a tumor infiltrating lymphocyte therapy for use in patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy. The company says it plans to complete the BLA submission in the fourth quarter.

The BLA is based on clinical data from the company’s C-144-01 clinical trial. As reported in May, Cohort 4 from the study showed an objective response rate (ORR) of 29%, with three complete responses and 22 partial responses, the company says. The median duration of response was 10.4 months with a median study follow-up of 23.5 months. “These data demonstrate that one-time treatment with lifileucel therapy may provide meaningful benefit in heavily pre-treated patients,” it says. Cohort 4’s findings are supported by Cohort 2, where the ORR was 35% ,with five complete responses and 18 partial responses, the company adds.

The company says that the therapy uses a patient’s own immune cells to attack solid tumors. In 2021, Iovance delayed the BLA submission after receiving FDA regulatory feedback on potency assays for the product. Previously, FDA granted a regenerative medicines advanced therapy designation for lifileucel.

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