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FDA Greenlights Early-Line Use of Janssen and Legend Biotech’s Carvykti for Multiple Myeloma

NextEdge Admin

05 Apr 2024

2 min 30 sec

The US Food and Drug Administration recently granted approval for Janssen Biotech and Legend Biotech’s CAR T-cell therapy, Carvykti, as an early-line treatment for relapsed or refractory multiple myeloma. This decision stems from the promising outcomes of the Phase III CARTITUDE-4 trial. Patients treated with Carvykti showcased prolonged progression-free survival compared to those on standard therapies such as Pomalyst with bortezomib and dexamethasone or Darzalex with Pomalyst and dexamethasone. Notably, after a year, survival rates were substantially higher in the Carvykti arm. Moreover, Carvykti exhibited a superior overall response rate.

To qualify for the trial, patients must have undergone one to three prior lines of therapy, including specific drugs, and demonstrated resistance to Revlimid. Those previously treated with CAR T-cell therapy or BCMA-targeted therapy were ineligible.

Previously approved for patients with extensive treatment history, this new approval allows Carvykti to be administered earlier, potentially at the first relapse. The FDA’s Oncologic Drugs Advisory Committee endorsed this decision, acknowledging the therapy’s ability to provide patients with crucial treatment breaks and emphasizing the necessity for seamless transitioning strategies.

Janssen plans to expand Carvykti’s manufacturing capacity to accommodate increased demand following this approval. Tyrone Brewer, president of J&J’s Innovative Medicine hematology division, expressed the company’s commitment to ensuring broad access to this critical therapy.

Simultaneously, the FDA sanctioned BMS and 2seventy bio’s CAR T-cell therapy, Abecma, for patients with relapsed or refractory multiple myeloma after two or more prior treatments. Abecma’s approval extends its reach after being granted earlier-line usage in various international regions.