Johnson & Johnson’s Multiple Myeloma Treatment Wins Accelerated Approval

On August 24, Johnson & Johnson’s Janssen Pharmaceutical Companies announced their TECVAYLI® (teclistamab) received conditional marketing authorization (CMA) from the European Commission (EC). TECVAYLI is a monotherapy for adult patients with relapsed and refractory multiple myeloma (RRMM). The Phase 1/2 MajesTEC-1 study supported the EC’s granting of the accelerated approval.

Related Article: Oncopeptides’ Pepaxti Won EMA Approval for Multiple Myeloma

TECVAYLI’s Treatment of Multiple Myeloma Differs

Multiple myeloma is a cancer formed in a person’s white blood cells. These cells, also called plasma, assist the immune system by creating antigens. Multiple myeloma is when these cells become cancerous. The corrupted cells begin producing abnormal proteins that cause complications in the immune system. These include inhibiting the body’s ability to fight infections, bone thinning, reduced kidney function, and anemia. 

While there is no cure for multiple myeloma, various treatments are available. For example, one recently approved by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is Pepaxti. Developed by Oncopeptides, Pepaxti delivers cancer-killing enzymes directly to cancer cells containing high levels of abnormal proteins. Other promising treatments in development, such as Bristol Myers Squibb’s NINLARO, function similarly.

However, TECVAYLI takes a slightly different approach to treating multiple myeloma. Though Janssen’s treatment still uses the proteins expressed by the cancer cells, it alerts the body’s T-cells after binding. Once activated, the T-cells seek and destroy myeloma cells. Due to this treatment’s potential in its clinical trial, the CHMP evaluated TECVAYLI’s under an accelerated timeline. 

The MajesTEC-1 Study Wins TECVAYLI a CMA

MajesTEC-1 study (comprised of NCT03145181 and NCT04557098) is an open-label Phase ½ study evaluating the safety and efficacy of TECVAYLI in adults with RRMM. After receiving weekly subcutaneous injections of the treatment, 104 out of 105 patients showed an overall response rate of 63%. In addition, patients demonstrated a median progression-free survival of 11.3 months and a median overall survival of 18.3 months.

On the effectiveness of the treatment, Maria-Victoria Mateos, M.D., Ph.D., Consultant Physician in Haematology at the University Hospital of Salamanca, said, “Teclistamab has the potential to provide substantial clinical benefit and new hope to these patients, with high rates of deep and durable responses, and the added convenience of being off-the-shelf.”

Due to the results, the EC granted TECVAYLI a CMA. The EC gives these accelerated approvals to medicines that, although lacking in the comprehensive data typically required for approval, address unmet medical needs. However, despite believing that the immediate availability of the drug outweighs the risk, the EC expects applicants to provide further comprehensive clinical data in the future.

The conditional approval from the EC marks the first worldwide approval of TECVAYLI. In the future, Janssen plans continued testing of TECVAYLI in ongoing clinical trials. The company will likely file further applications to other regulatory boards.

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Author

Max Heirich