PharmaMar, Jazz get FDA priority review for lung cancer drug

PharmaMar, Jazz get FDA priority review for lung cancer drug

The FDA has accepted PharmaMar and Jazz Pharmaceuticals’ small cell lung cancer (SCLC) drug for priority review. Getting lurbinectedin on the fast track tees the partners up to learn whether the FDA will approve the drug by mid-August.

PharmaMar filed for FDA approval of lurbinectedin late last year on the strength of data suggesting the drug improves outcomes in SCLC patients by inhibiting activated transcription and inducing DNA double-strand breaks to trigger cell death. Days later, Jazz agreed to pay $200 million (€185 million) upfront for the U.S. rights to lurbinectedin.

Landing a priority review at the FDA may pull forward the date on which PharmaMar receives more money from Jazz. The deal includes up to $250 million in regulatory milestones tied to the approval of lurbinectedin within certain timelines.

The FDA’s acceptance of lurbinectedin for priority review reflects the unmet medical need in SCLC. While the FDA has approved Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda for third-line use in recent years, the options available to second-line patients have remained unchanged.

Lurbinectedin could win approval as a second-line therapy, becoming the first new chemical entity (NCE) authorized for sale by the FDA for use in SCLC for more than 20 years in the process. The FDA last approved a NCE in second-line SCLC in 1996 when it authorized SmithKline Beecham to market Hycamtin in the indication.

PharmaMar and Jazz’s bid to end the long wait for a NCE in second-line SCLC is underpinned by data from a clinical trial cohort that enrolled 105 patients. More than one-third of patients responded to the drug. The response rate was highest in patients with chemotherapy-free intervals of more than 90 days.

If lurbinectedin comes to market, Jazz will compete with products including Hycamtin, Opdivo and Keytruda for relapsed SCLC patients. PharmaMar has also generated evidence that lurbinectedin can work in patients previously treated with immuno-oncology drugs, racking up a response rate of over 60% in a small subset of subjects with that care history.

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