Rival Gilead and Novartis cancer therapies get EMA recommendation

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Rival cancer cell therapies from Swiss drugmaker Novartis and US-based Gilead Sciences have won a key recommendation from a European Medicines Agency panel, likely clearing their way for approval within months.

Reuters Health reports that 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 US.

Gilead’s Yescarta, which also has US 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).

The report says 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. Yescarta reaped $40m in revenues in the first quarter, while Novartis, which has predicted eventual blockbuster status for Kymriah, brought in $12m for its therapy in the ALL setting.

The report says Gilead gained access to Yescarta with its nearly $12bnm deal last August, a deal in which it was looking for a lucrative cancer drug to help offset flagging sales of its long-time mainstay hepatitis C medicines.

The CHMP recommended Roche’s RoActemra, known as Actemra in the US, because it has helped CAR-T patients who develop potentially fatal cytokine release syndrome, notably saving the life of a six-year-old girl. The report says 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 US Food and Drug Administration (FDA) has already expanded Actemra’s use in the US.

Reuters Health report

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