FDA declines to approve ImmunityBio's bladder cancer therapy…
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May 11 (Reuters) - ImmunityBio Inc said on Thursday the U.S.
Food and Drug Administration has declined to approve its combination therapy to treat a type of bladder cancer due to deficiencies in the company's application.
Shares of the therapy developer slumped nearly 57% to $2.69 in premarket trading.
ImmunityBio, in a filing with the Securities and Exchange Commission, also reiterated doubts about its ability to remain in business.
The application was for its lead therapy anktiva in combination with the Bacillus Calmette-Guérin vaccine, which is mainly used against tuberculosis. The combination was aimed at treating patients with BCG-unresponsive non-muscle invasive bladder cancer.
In a letter to the company on Tuesday, the health regulator flagged deficiencies related to the FDA's pre-license inspection of the company's third-party contract manufacturing firms.
The FDA said it cannot approve the application in its present form, and made recommendations about how the manufacturing issues could be resolved.
The health regulator did not request any new preclinical or late-stage clinical trials to evaluate the safety or efficacy of the therapy, but requested the company to provide more data and a safety update in its resubmission.
The company plans to request a meeting with the FDA as soon as possible to address the matter, resolve the issues identified and seek approval as fast as possible.
ImmunityBio also said it has confirmed with a potential partner that it will continue negotiations for commercialization of the therapy notwithstanding the FDA's letter.
(Reporting by Sriparna Roy in Bengaluru; Editing by Arun Koyyur and Devika Syamnath)
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Food and Drug Administration has declined to approve its combination therapy to treat a type of bladder cancer due to deficiencies in the company's application.
Shares of the therapy developer slumped nearly 57% to $2.69 in premarket trading.
ImmunityBio, in a filing with the Securities and Exchange Commission, also reiterated doubts about its ability to remain in business.
The application was for its lead therapy anktiva in combination with the Bacillus Calmette-Guérin vaccine, which is mainly used against tuberculosis. The combination was aimed at treating patients with BCG-unresponsive non-muscle invasive bladder cancer.
In a letter to the company on Tuesday, the health regulator flagged deficiencies related to the FDA's pre-license inspection of the company's third-party contract manufacturing firms.
The FDA said it cannot approve the application in its present form, and made recommendations about how the manufacturing issues could be resolved.
The health regulator did not request any new preclinical or late-stage clinical trials to evaluate the safety or efficacy of the therapy, but requested the company to provide more data and a safety update in its resubmission.
The company plans to request a meeting with the FDA as soon as possible to address the matter, resolve the issues identified and seek approval as fast as possible.
ImmunityBio also said it has confirmed with a potential partner that it will continue negotiations for commercialization of the therapy notwithstanding the FDA's letter.
(Reporting by Sriparna Roy in Bengaluru; Editing by Arun Koyyur and Devika Syamnath)
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