Y-mAbs Therapeutics (YMAB) and Takeda (TAK) Granted Marketing Authorization in Israel for DANYELZA – StreetInsider.com

Posted By on August 30, 2022

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Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer and Takeda Israel, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (NYSE: TAK), announced today that the Israeli Ministry of Health has approved DANYELZA in Israel for the treatment, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

In Israel, DANYELZA is expected to be commercialized by Takeda Israel, under the exclusive license and distribution agreement entered in 2020 between Takeda Israel and the Company.

The regulatory approval of DANYELZA in Israel represents our first marketing authorization outside of the U.S. and is a milestone for our collaboration with Takeda and more importantly for the pediatric patients we are dedicated to serving, said Thomas Gad, President, and Interim Chief Executive Officer. The approval in Israel further demonstrates our commitment to expanding the reach of our commercial stage products internationally to patients with unmet medical needs.

We are extremely excited by the approval of DANYELZA in Israel, said Arie Kramer, General Manager of Takeda Israel. This registration, following the expedited reimbursement of the product last December by the Israeli Ministry of Health, allowing Takeda and Y-mAbs to offer a new innovative treatment for pediatric neuroblastoma patients in Israel, is in alignment with Takedas vision of Better Health and Brighter Future to every patient in the world.

Researchers at Memorial Sloan Kettering Cancer Center (MSK) developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

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Y-mAbs Therapeutics (YMAB) and Takeda (TAK) Granted Marketing Authorization in Israel for DANYELZA - StreetInsider.com

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