ImmunityBio And Rafa Laboratories Say Israeli MoH Grants Approval For ANKTIVA, Indicated In Combination With BCG For Treatment Of Adult Patients With BCG-Unresponsive NMIBC With CIS With Or Without Papillary Tumors
Benzinga Newsdesk 1 hour ago
News
Partnership brings first-in-class IL-15 receptor agonist immunotherapy to patients in IsraelIsraeli Ministry of Health grants approval for ANKTIVA® (nogapendekin alfa inbakicept) in combination with BCG for adult
- Partnership brings first-in-class IL-15 receptor agonist immunotherapy to patients in Israel
- Israeli Ministry of Health grants approval for ANKTIVA® (nogapendekin alfa inbakicept) in combination with BCG for adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors
- Approval granted four months after submission under an accelerated review pathway; registration license expected within the coming weeks
- ANKTIVA® is now authorized in 35 countries; Rafa Laboratories to lead commercialization in Israel as exclusive partner
ImmunityBio, Inc. ((IBRX) ("ImmunityBio") and Rafa Laboratories Ltd. (TASE: RAFA) ("Rafa") today announced that the Israeli Ministry of Health (MoH) has granted approval for ANKTIVA® (nogapendekin alfa inbakicept), indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The approval was granted four months after submission under an accelerated review pathway. The registration license is expected within the coming weeks.
Under the distribution agreement between the companies, Rafa will be the exclusive commercialization partner for ANKTIVA in Israel, bringing together ImmunityBio’s innovative immunotherapy platform and Rafa’s established capabilities and presence in the Israeli healthcare market.
ANKTIVA is a first-in-class IL-15 receptor agonist immunotherapy designed to activate natural killer (NK) cells and T cells and drive their proliferation. In the United States, ANKTIVA was approved by the U.S. Food and Drug Administration in April 2024 in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors. The FDA subsequently expanded the label for ANKTIVA in combination with BCG to include adults with BCG-unresponsive NMIBC, including those with papillary-only disease.