USA — The US Food and Drug Administration (FDA) has approved Eli Lilly and Co.’s drug (pirtobrutinib) for the treatment of a rare form of blood cancer.

The indication aims to treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

The drug will retail under the brand name Jaypirca’s, and its accelerated approval by the Food and Drug Administration is the first of five treatments that the U.S. drugmaker hopes to launch this year, including one for obesity.

According to Lilly, the drug will be available in the United States in the coming weeks, and it will retail for a list price of US$21,000 for a 30-day supply for the 200 mg dose.

Prior to Jaypirca, the FDA approved three Bruton’s tyrosine kinase (BTK) inhibitors: Imbruvica from AbbVie and Johnson & Johnson, Calquence from AstraZeneca, and Brukinsa from BeiGene.

However, Jaypirca is distinct from those products, and Lilly is primarily targeting a different market, according to Jake Van Naarden, CEO of Lilly’s oncology unit Loxo.

Mantle cell lymphoma is a rare type of blood cancer that begins in white blood cells in lymph nodes and spreads rapidly to other parts of the body.

The FDA granted approval based on the results of the BRUIN trial, which included 120 patients with relapsed or refractory mantle cell lymphoma who had received a covalent BTK inhibitor in phase 1 or phase 2. Prior therapies had been administered to a median of three (range, 1-9) patients.

Participants in the study were given 200 mg pirtobrutinib once daily until disease progression or unacceptable toxicity. The researchers reported an overall response rate of 50% and a complete response rate of 13%.

In a safety analysis, 128 patients with mantle cell lymphoma were included, with 4.7% requiring dose reductions, 32% requiring treatment interruption, and 9% discontinuing treatment due to adverse reactions.

Jaypirca is a selective non-covalent BTK inhibitor, whereas the three previous products are covalent BTK inhibitors that cannot be used sequentially.

Jaypirca binds to BTK differently and can thus be used following progression on another BTK inhibitor.

Jaypirca has a unique opportunity to treat patients who have failed on other BTK inhibitors, and most blood cancer patients eventually progress on covalent BTK.

Jaypirca’s approval is a significant boost for Lilly’s oncology business, following the FDA’s humiliating rejection of then-Innovent Biologics-partnered PD-1 inhibitor Tyvyt (sintilimab) last year.

It also comes on the heels of the FDA’s unexpected rejection of the closely watched Alzheimer’s disease drug donanemab last week.

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