03 March 2022

Another CAR-T

FDA approves new CART-T therapy against multiple myeloma

Nikolay Sokolov, Farmvestnik


The US FDA has approved a drug developed by Johnson & Johnson and its Chinese partner Legend Biotech for the treatment of adults with recurrent or refractory multiple myeloma. The drug Carvykti / Cilta-cel is administered after four or more unsuccessful previous courses of therapy. This is stated on the website of the American manufacturer.

Carvykti/Cilta-cel belongs to a class of vehicles known as CAR-T. Using this technology, T-cells are taken from patients, modified by "sewing on" the receptor, and injected anew into the patient. The Carvykti/Cilta-cel receptor detects and eliminates tumor cells expressing the B-cell maturation antigen, or BCMA.

Initially, it was expected that a decision on this drug would be made by the end of November after it was granted priority consideration status six months ago. However, it took another three months to review all the information provided by J&J at the request of the FDA.

Legend, which initiated the development, signed an agreement with Janssen Biotech, a division of J&J, in 2017 on the joint development and commercialization of the drug. Legend received an advance payment of $350 million. Legend and J&J will sell the drug in mainland China in the proportion of 70/30 (70% for Legend and 30% for J&J), and in all other countries – 50/50.

"This is the first of many cell therapies that we plan to offer to patients as we continue to expand our portfolio in relation to various diseases," said Legend's chief executive officer and chief financial officer of the company Ying Huang.

In addition to the United States, Carvykti/Cilta-cel is also being studied by health regulators in Japan and Europe. The application for a trade license in China has not yet been submitted.

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