Drugs

Janssen sBLA for Darzalex in Real Time Review Pilot

Janssen Biotech has submitted the first part of a supplemental BLA for a label expansion to include the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant. The agency plans to review the submission under its Real-Time Oncology Review pilot program, according to the company.

The filing is based on data from the Phase 3 MAIA (MMY3008) study of daratumumab in combination with lenalidomide and dexamethasone as treatment for patients with newly diagnosed multiple myeloma. Patients in the two treatment arms will continue treatment with lenalidomide and dexamethasone until disease progression or unacceptable toxicity. The primary endpoint of the study is progression free survival, according to the company.

Darzalex is currently indicated in combination with bortezomib, melphalan and prednisone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for treating patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for treating patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor; and as a monotherapy for treating patients with multiple myeloma who have received at least three prior lines of therapy.

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