The FDA has approved the use of Novartis’ CAR-T therapy Kymriah in adult patients with diffuse large B-cell lymphoma (DLBCL), an indication where it will compete with Gilead’s Yescarta.
Kymriah (tisagenlecleucel) became last year the first CAR-T therapy to ever be approved. This new type of treatment is now offering hope to patients with hard-to-treat types of cancer that previously had no options, by engineering their own T cells to attack cancer cells.
A few months after Novartis’ Kymriah was approved, Gilead got approval for a second CAR-T treatment, called Yescarta. Until now, both treatments were approved in different forms of cancer, but the FDA has announced today that from now on, Kymriah is also approved in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) — the same indication where Yescarta was initially approved.
The news comes just a week after Novartis announced that the sales of Kymriah were significantly lower than expected for the first quarter of the year. The addition of a new cancer indication could help Novartis pick up the pace, but competing with Gilead might limit its ability to reach new patients. Especially when the price of Yescarta, although high, is significantly lower that Kymriah’s — $373,000 versus $475,000.
Still, this is great news for cancer patients, as it could improve access to this new technology. Currently, the supply of CAR-T cells is restricted to specific sites where the whole procedure can take place, including the shipment of the patient’s cells to and from the lab where they are engineered.
Hopefully, we’ll see CAR-T cells taking over the cancer space as the treatment is approved in more forms of cancer and new therapies beyond the two currently available are launched. Several companies are already working on off-the-shelf versions that could make the procedure faster and cheaper and on CAR-T cells that work in more common types of blood cancer as well as solid tumors.
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