Taiho Oncology Announces New England Journal of Medicine Publication of First All-Oral Regimen in Newly Diagnosed Acute Myeloid Leukemia
Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, today announced the publication in the New England Journal of Medicine of results from the ASCERTAIN-V Phase 1/2 clinical trial, which evaluated the first all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy. The study demonstrated favorable response rates and survival with expected myelosuppressive effects.1
U.S. FDA Approves INQOVI® in Combination with Venetoclax, the First All-Oral Combination Treatment for Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Chemotherapy
Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd., today announced that the U.S. Food and Drug Administration (FDA) has approved INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy. INQOVI in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits.
U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.
Taiho Oncology Appoints Peter Melnyk as President & Chief Executive Officer
Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, announced today Peter Melnyk has been appointed to President & Chief Executive Officer, effective immediately. Mr. Melnyk succeeds Tim Whitten, who has retired after 13 years of service.
Peter Melnyk Joins Taiho Oncology as President & Chief Operating Officer
Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, announced today Peter Melnyk has joined the company as President & Chief Operating Officer.
