Incyte Says Withdrawing NDA for Parsaclisib Is a 'Business Decision'
January 25 2022 - 5:43PM
Dow Jones News
By Stephen Nakrosis
Biopharmaceutical company Incyte Corp. on Tuesday said it was
withdrawing its new drug application for parsaclisib to treat
certain lymphoma patients following discussions with the Food and
Drug Administration.
The company said it would withdraw its NDA for parsaclisib "for
the treatment of patients with relapsed or refractory follicular
lymphoma, marginal zone lymphoma and mantle cell lymphoma."
According to the company, the decision to withdraw the
application came after talks with the FDA regarding confirmatory
studies to support an accelerated approval. The company said it
determined the studies couldn't be completed within a time period
that would support the investment.
"The withdrawal of the NDA is a business decision and is not
related to any changes in either the efficacy or safety of
parsaclisib," Incyte said.
The company also said its decision "impacts only the FL, MZL and
MCL indications in the U.S., and does not affect other ongoing
clinical trials in the U.S. or other countries."
The company also said it decided to opt out of the continued
development of MCLA-145, a CD137/PD-L1 bispecific antibody which
was being co-developed under a global collaboration and license
agreement with Merus.
Incyte said it will "continue to collaborate with Merus and
leverage their platform to develop a pipeline of novel agents."
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
January 25, 2022 17:28 ET (22:28 GMT)
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