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Gilead’s second act in cell therapy gets its first approval

Kite Pharma, a cell therapy developer owned by Gilead, announced Friday that the Food and Drug Administration has approved one of its treatments for a rare type of blood cancer.Gilead will sell the one-time therapy under the brand name Tecartus and at a list price of $373,000. Tecartus is now cleared for adults with mantle cell lymphoma who either didn’t respond to other treatments or saw their cancer progress after getting them. Drugs from AstraZeneca and China’s BeiGene have received similar approvals in the last few years.The FDA’s decision marks the third approval for a so-called CAR-T cell therapy since 2017, the same year that Gilead bet heavily on these medicines with its $12 billion acquisition of Kite. Though the deal has now yielded two approved products, CAR-T treatments have struggled commercially, rendering them a niche oncology business thus far.

Cell therapies have shown remarkable effects in the treatment of certain blood cancers. Yet, from a business perspective, they have yet to meet their high expectations. Sales of Gilead’s Yescarta and Novartis’ Kymriah, the first two CAR-T cell therapies on the U.S. market, have been modest, reflecting the small number of patients for which they’re approved and the complicated, multi-week process involved in treating them.

Tecartus is now the third such treatment to receive an FDA OK, and the first cleared for use in relapsed or refractory mantle cell lymphoma.Like its predecessors, Tecartus will be available to relatively few patients. Mantle cell lymphoma is an uncommon cancer that, according to some estimates, accounts for just 2% to 7% of adult cases of non-Hodgkin’s lymphomas in the U.S. and Europe.

Gilead priced Tecartus at $373,000, the same price tag its other cell therapy Yescarta has for a different form of advanced lymphoma. That figure is well north of the cost of other drugs approved for mantle cell lymphoma. AstraZeneca’s Calquence, for example, carried a list price of $14,259 per month when it was first approved in late 2017. A 30-day supply of BeiGene’s Brukinsa, meanwhile, costs around $13,000, or $156,000 per year, before discounts and rebates.

Calquence, Brukinsa, and Johnson & Johnson’s Imbruvica work differently than Tecartus. They’re chemical-based drugs that target an enzyme known as BTK or Bruton’s tyrosine kinase.

A Gilead spokesperson said the company looked at third-party market research when deciding on a price for Tecartus. It also considered the therapy’s “clinical attributes,” namely the response rate seen in pivotal testing and the fact that median duration of response — which measures how long after treatment a patient’s cancer starts to progress — hadn’t been reached after at least six months of follow-up. MCL patients who fail multiple treatments, including BTK inhibitors, currently live a median of six to 10 months with available treatments, the spokesperson said.

“Once you’ve exhausted the usual standard of care, the prognosis is grim,” said Ken Takeshita, head of clinical development at Kite, in a recent interview.

In a statement from Gilead, Meghan Gutierrez, CEO of the Lymphoma Research Foundation, said the approval of Tecartus builds on advances made over the past decade in treating mantle cell lymphoma and “provides hope” to patients.

Friday’s approval also provides Gilead a second market-ready drug from its $12 billion acquisition of Kite. It was cleared to begin selling Yescarta just months after buying Kite in 2017.

While Gilead, under recently minted CEO Daniel O’Day, has made hiring and structural moves to make Kite more effective, the acquisition hasn’t gone over well with investors.

That’s due in part to the deal’s high price tag, but also because Kite has yet to lift Gilead’s cancer drug business. The sizable investment in CAR-T is crucial to Gilead’s strategy of getting that business to complement its core HIV and hepatitis franchises. Yet Yescarta sales were flat over much of 2019, reaching a little more than $450 million by the end of the year.