
Incyte Withdraws FDA Submission for Parsaclisib for FL, MZL, MCL
Incyte has become the latest company to pull an FDA filing following Gilead and Secura Bio, which both voluntarily withdrew therapies that had been granted accelerated approval but hadn’t completed confirmatory studies for full approval.
Incyte has
The
According to the company, the decision was made after discussions with the FDA “regarding confirmatory studies to support an accelerated approval, which Incyte determined cannot be completed within a time period that would support the investment.”
The company’s decision only impacts the FL, MZL, and MCL indications in the United States and does not affect other ongoing trials.
The move comes shortly after Gilead Sciences
Idelalisib was granted accelerated approval in combination with rituximab (Rituxan) in July 2014 based on results of a phase 2 trial that found idelalisib had an objective response rate (ORR) of 54% in patients with FL and 58% in patients with SLL. However, the continued approval for these indications was contingent on providing evidence to support confirmation of the clinical benefit in FL and SLL.
According to Gilead, “enrollment into the confirmatory study has been an ongoing challenge,” which led to the decision to voluntarily withdraw these indications.
Idelalisib will remain on the market in the US for chronic lymphocytic leukemia (CLL).
Kite, a Gilead company, currently has the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel (axi-cel; Yescarta) approved to treat large B-cell lymphoma or FL after 2 or more lines of systemic therapy. In October 2021,
At the 63rd Annual American Society of Hematology Meeting and Exposition, the lead author of ZUMA-7
The trial has shown that axi-cel improved event-free survival (EFS) more than 60% over standard of care (SOC). The median EFS was 8.3 months for axi-cel vs 2.0 months for SOC, and the ORR was 83% for axi-cel vs 50% for SOC.
Even before Gilead,
In December 2021,
Duvelisib will remain on the market in the United States for CLL and SLL.
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