With Bristol Myers Squibb’s approval last month for CAR-T medicine Breyanzi, a third entrant is vying for share in the lymphoma cell therapy arena. But now Gilead Sciences' Yescarta has scored an approval its rivals can’t yet match.
The FDA on Friday approved Yescarta to treat patients with relapsed or refractory follicular lymphoma after at least two prior lines of treatment. It’s the industry's first CAR-T approval in indolent follicular lymphoma and the third approved use for a Gilead cell therapy.
Yescarta scored the new approval based on data from a single-arm, open-label study called Zuma-5. In the study, 91% of patients responded to treatment with the drug, and an estimated 74% were in continued remission at 18 months.
Meanwhile, 21% of patients experienced grade 3 or worse neurologic side effects, while 8% suffered the severe immune over-reaction called cytokine storm. The FDA added a boxed warning to the drug's new use and is requiring a risk evaluation and mitigation strategy through the treatment process.
Follicular lymphoma, a form of indolent non-Hodgkin lymphoma, is the second most common form of lymphoma worldwide, accounting for around 22% of diagnoses, Gilead said. Patients' malignant tumors start to grow slowly but become more aggressive over time, and there are “limited options” for treatments after the second line of therapy, Gilead says.
After a patient’s follicular lymphoma relapses, “the duration of response to care shortens with each round of therapy,” Caron Jacobson, medical director of the Immune Effector Cell Therapy Program at the Dana-Farber Cancer Institute, said in a statement.
At the third line of therapy, five-year survival is only 20%, Jacobson said, so there remains an “urgent need for treatments that offer a real chance for durable remission." The Yescarta approval gives patients “much-needed hope and oncologists an important addition to the treatment armamentarium.”
Earlier in the regulatory process, Yescarta scored a breakthrough designation and a priority review from the FDA in the indication. The approval marks a “real step forward” in the company’s “commitment in hematologic malignancies,” Christi Shaw, CEO of Gilead's CAR-T outfit Kite Pharma, said in a statement.
Yescarta’s latest approval adds a new use to the med’s label that its rivals don't have. In October 2017, the drug became the first CAR-T med to score an FDA nod in relapsed or refractory large B-cell lymphoma. Novartis’ Kymriah scored its own FDA approval in the disease the following May, and last month, Bristol Myers Squibb’s Breyanzi entered the fray, setting up a three-way market share battle between the drugmakers.
In follicular lymphoma, Novartis’ Kymriah may not be too far behind. In December, the company touted data at the American Society of Hematology virtual annual meeting showing that Kymriah could erase all signs of cancer in 65% of previously treated follicular lymphoma patients and spur responses in 83% of them.
At the time, Novartis’ chief medical officer John Tsai said the disease has been considered “incurable” and that “any advance in this area is really seen as a breakthrough." Novartis is planning to submit the data to regulators this year.