Janssen Submits Biologics License Application for Talquetamab

According to a recent press release, Janssen recently submitted a Biologics License Application (BLA) to the FDA for talquetamab to treat relapsed or refractory multiple myeloma. The CDC states that myeloma is cancer in plasma cells that make antibodies, otherwise known as white blood cells. For myeloma patients, these cells grow uncontrollably, preventing the creation of red blood cells, platelets, and other white blood cells. Multiple myeloma begins in the bone marrow and can spread throughout the body.

The press release notes that approximately 34,000 people are diagnosed with multiple myeloma in the United States each year. Additionally, 12,000 people in the US die from multiple myeloma annually.

Symptoms of myeloma can include bone pain, fragile bones, fever without an underlying cause, recurrent or frequent infections, bruising, bleeding, difficulty breathing, arm or leg weakness, and fatigue.

"Despite the therapies that have been developed for the treatment of multiple myeloma, there remain persistent unmet needs for patients who relapse or become refractory," said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head, Oncology, Janssen Research and Development, in the press release. "Through our discovery and development of talquetamab, a novel GPRC5DxCD3 bispecific antibody, we remain relentlessly committed to the investigation of innovative therapies for patients and oncologists. We look forward to working closely with the FDA in their review of the talquetamab submission."

According to the press release, talquetamab is an investigational bispecific T-cell antibody. It targets GPRC5D, a common multiple myeloma target, and CD3, part of the T-cell receptor.

Currently, the drug is in Phase 1 and 2 clinical trials for treating relapsed or refractory multiple myeloma. It is administered via subcutaneous injection. The medication already received the PRIME designation in Europe in January 2021. Additionally, the FDA granted it Orphan Drug designation in August 2021 and Breakthrough Therapy designation in June 2022. Thus far, it is only used in adults who have received four previous treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.