June 29 - Rival cancer cell therapies from Swiss drugmaker Novartis and U.S.-based Gilead Sciences won a key recommendation from a European Medicines Agency panel, likely clearing their way for approval within a couple of months.
The Committee for Medicinal Products for Human Use (CHMP) recommended Novartis’s Kymriah for treatment of B cell acute lymphoblastic leukaemia (ALL) and diffuse large B cell lymphoma (DLBCL). Kymriah was the first so-called chimeric antigen T-cell therapy (CAR T) to be approved in the United States.
Gilead's Yescarta, which also has U.S. approval in blood cancer, got the CHMP's nod in DLBCL, where it would go head-to-head with Novartis's medicine, as well as in primary mediastinal B-cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). (bit.ly/2Ky9Rwj)
The recommendations are usually followed by the European Commission, which must issue final approval before the medicines can be sold in Europe.
Both companies’ CAR T therapies are one-time treatments in which immune cells are removed from patients, genetically engineered in the laboratory using disarmed virus to target their blood cancers, and then re-infused.
Kymriah is priced at $475,000 in the United States in its original indication for young people up to 25 with ALL, and at $373,000 for DLBCL, which matches Yescarta’s U.S. price.
Prices in Europe will likely vary, as the companies reach deals with agencies in individual companies.
Yescarta reaped $40 million in revenues in the first quarter, while Novartis, which has predicted eventual blockbuster status for Kymriah, brought in $12 million for its therapy in the ALL setting.
Gilead gained access to Yescarta with its nearly $12 billion deal last August, a deal in which it was looking for a lucrative cancer drug to help offset flagging sales of its longtime mainstay hepatitis C medicines. (Reporting by John Miller in Zurich; additional reporting by Muvija M in Bengaluru; Editing by Shailesh Kuber)