Drugs

Starton OK’d for Multiple Myeloma Trial

FDA has given Starton Therapeutics the green light to proceed with a Phase 1b clinical trial of its Star-LLD investigational continuous delivery lenalidomide in multiple myeloma. The trial in second-line transplant-ineligible patients is designed to assess the combination of Star-LLD, Velcade, and dexamethasone, according to the company. It will evaluate six patients for tolerability, immune biomarkers, and efficacy signals for continuously delivered lenalidomide at the highest planned daily dose, it says. Enrollment is planned for the fourth quarter.

Under the drug’s development plans, FDA has agreed to have a meeting to review initial data on safety and activity from the study as an interim analysis, Starton says. “This interim review is aimed at helping develop the plans for the approval path forward with Phase 2 studies for multiple myeloma, as well as other malignancies where lenalidomide has shown activity but is not approved for the new indications planned for study,” it adds.

The company says a preclinical proof-of-concept study for Star-LLD demonstrated that multiple myeloma tumors grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and they shrank by 80% with Star-LLD.

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