UK MHRA Grants Marketing Authorization for ImmunityBio's ANKTIVA Plus BCG for Bladder Cancer Treatment
Reuters
Jul 08
UK MHRA Grants Marketing Authorization for ImmunityBio's ANKTIVA Plus BCG for Bladder <a href="https://laohu8.com/S/CTHZ">Cancer Treatment</a>
ImmunityBio, Inc. has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin $(BCG)$ for the treatment of certain bladder cancer patients. This marks the first marketing approval for this novel lymphocyte-stimulating agent outside the U.S. ANKTIVA, already approved in the U.S. and designated as a Breakthrough Therapy by the FDA, offers a new treatment option for the 16,400 to 18,000 individuals diagnosed with Non-Muscle Invasive Bladder Cancer (NMIBC) in the UK annually. The company has also submitted regulatory applications to the European Medicines Agency to expand availability across the EU and other European countries.
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