Novartis seeks Kymriah nod in lymphoma, setting up Gilead CAR-T showdown

Novartis has applied for FDA approval with Kymriah to treat relapsed/refractory diffuse large B-cell lymphoma. (Novartis)

Cutting-edge cell therapies from Novartis and Gilead Sciences aren't direct competitors for now, but that could change—and soon. The Swiss drugmaker's Kymriah is now up for an FDA approval in diffuse large B-cell lymphoma, one of the lymphoma types treated by Gilead's Yescarta.

On Tuesday, Novartis asked the FDA to approve Kymriah for patients with relapsed or treatment-resistant DLBCL who are ineligible for stem cell transplants. It's a group of patients also covered by Gilead's Yescarta approval, granted by the FDA earlier this month.  

DLBCL would be the second indication for Novartis' Kymriah following its groundbreaking nod back in August to treat relapsed or refractory acute lymphoblastic leukemia (ALL) in patients up to 25 years of age. With that approval, Novartis priced its therapy at $475,000 and introduced a money-back guarantee for certain patients who don't respond. 

In a note following Kymriah's approval, Bernstein analyst Tim Anderson wrote that the med's sales prospects in ALL are relatively limited at up to $300 million per year, because of the relatively small number of patients. DLBCL and its larger patient pool represents a larger opportunity, but with one caveat: The "offset to a larger population would be a lower price most likely," Anderson wrote, because Novartis has said it intends to price its drug depending on the type of cancer treated. 

For its part, Gilead acquired its CAR-T drug through its $11.9 billion Kite Pharma buyout in August; the drugmaker priced Yescarta at $373,000 for DLBCL. 

CAR-T pricing decisions also include manufacturing costs for the complex therapies, which involve collecting a patient's T cells, re-engineering them and reinfusing them to fight cancer. Both CAR-T meds are one-time treatments that carry the potential for a cure for patients without other options. 

According to Novartis, DLBCL is the most common type of non-Hodgkin lymphoma. Fifty percent to 60% of patients respond to initial treatments, but one-third of patients relapse after a second round of therapy; most aren't eligible for stem cell transplants. The disease has a life expectancy of three to four months if untreated. 

Novartis' DLBCL application is based on a phase 2 study dubbed Juliet, which enrolled 27 patients in 10 countries. The data aren't public yet, but Novartis said it plans to present detailed results at the American Society of Hematology annual meeting in Atlanta in December. The company is also prepping regulatory filings in Europe for later this year and for other countries in 2018, according to its release.