| |AUGUST 20249US FDA NODS JOHNSON & JOHNSON'S DARZALEX FASPRO FOR PATIENTS WITH NDMMZYDUS RECEIVES MARKETING NOD FOR CANCER TREATMENT PRODUCTJohnson & Johnson stated that the FDA has given approval for Darzalex Faspro to be used in combination with D-VRd for induction and consolidation in eligible NDMM patients for ASCT. Patients will be able to get this Darzalex Faspro-containing quadruplet therapy at the start of their diagnosis, giving them a new treatment option that could greatly enhance results.The phase 3 PERSEUS study provided data backing the approval of Darzalex Faspro in a regimen that included D-VRd induction and consolidation therapy compared to VRd in NDMM patients eligible for ASCT. After the merger, patients were given an experimental maintenance treatment plan consisting of either Darzalex Faspro with lenalidomide or just lenalidomide."Multiple myeloma has a highly varied clinical course among patients and in each individual patient, and there is a continued need for innovation and therapies that employ different targets and combinations to provide patients with treatment options at diagnosis and throughout the course of their disease," said Amrita Y. Krishnan, M.D., Professor and Director of the Judy and Bernard Briskin Multiple Myeloma Center, City of Hope. "The efficacy data supporting this new quadruplet regimen, combined with its established safety and tolerability profile, provide compelling evidence that adding D-VRd upon initial diagnosis as compared to VRd can deepen responses and prolong remissions in the context of autologous stem cell transplantation". POZydus Lifesciences Ltd stated that the Mexican regulatory authority has approved the marketing of Mamitra, a Trastuzumab biosimilar for treating different cancer types. Mamitra is utilized for treating breast cancer as well as advanced stomach cancer. The company observed that breast cancer is now the most commonly diagnosed cancer in Mexico, surpassing prostate and colorectal cancers."The approval of Mamitra in Mexico allows us to expand the reach of our biosimilar portfolio to newer markets and enable access to affordable life-saving therapies, particularly in oncology," said Dr Sharvil Patel, managing director of Zydus.The drug can now be sold in various potencies of 150 mg and 440 mg, following approval from COFEPRIS.The research team at Zydus Research Centre (ZRC) internally developed the Trastuzumab biosimilar, which was released in India in 2016 as Vivitra. According to the company, around 100,000 patients have received treatment with the therapy since it was introduced.Zydus Lifesciences Limited, previously named Cadila Healthcare Limited, is an Indian multinational pharmaceutical company based in Ahmedabad, focusing mainly on producing generic drugs.Zydus Cadila develops and manufactures a wide variety of pharmaceuticals, diagnostics, herbal products, skincare products, and other OTC products in India through twenty-five pharmaceutical production operations. PO
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