Rival Novartis, Gilead CAR-T therapies win European panel recommendation

ZURICH: 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 months.

The Committee for Medicinal Products for Human Use (CHMP) recommended Novartis’s Kymriah for treatment of B cell acute lymphoblastic leukemia (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).

In a related move, the panel also recommended that the approval for Roche’s RoActemra medicine, typically prescribed for severe rheumatoid arthritis, be expanded to include the treatment of serious side effects of CAR-T cell therapies.

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.

The CHMP recommended Roche’s RoActemra, known as Actemra in the United States, because it has helped CAR-T patients who develop potentially fatal cytokine release syndrome, notably saving the life of a six-year-old girl.

She was the first paediatric ALL patient to get the drug that became Novartis’s Kymriah in 2011, and her successful treatment at Children’s Hospital of Pennsylvania helped to kick off the buzz in the medical world about the promise of CAR-T therapies.

The FDA has already expanded Actemra’s use in the United States.