Phyrago (dasatinib) / Handa Pharma, Cycle Group - LARVOL DELTA

Onco360 Has Been Selected as a Specialty Pharmacy Partner for PHYRAGO (dasatinib) (GlobeNewswire) - "Phyrago is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, for adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy."

Commercial • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia

Cycle Pharmaceuticals announces the launch of PHYRAGO, its first oncology product in the US. PHYRAGO is launched in partnership with Handa Therapeutics, LLC, and will be exclusively available through specialty pharmacy Onco360 with a specialty distribution network from McKesson, Cencora, and Cardinal Health. (Businesswire)

Launch US • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia

Cycle Pharmaceuticals Signs Exclusive U.S. Sales License for PHYRAGO (dasatinib) Tablets (Businesswire) - "Cycle Pharmaceuticals (Cycle Pharma) has entered into an exclusive U.S. commercialization agreement with Handa Therapeutics, LLC (Handa), for PHYRAGO, an FDA approved drug for treating two types of leukemia, Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)....Handa will be working closely with Cycle Pharma to launch PHYRAGO in September 2025. PHYRAGO will be launched with best-in-class patient support from Cycle Vita, providing individualized product, educational, and financial assistance to adult patients with Ph+ CML and Ph+ ALL."

Launch US • Licensing / partnership • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia

Handa Therapeutics Acquires FDA Approved Chronic Myeloid Leukemia Drug, PHYRAGO (dasatinib) Tablets (ACCESSWIRE) - "Handa Pharmaceuticals, Inc...announced that its U.S. subsidiary, Handa Therapeutics, LLC (the 'Company'), has acquired PHYRAGO (dasatinib) tablets, a U.S. Food and Drug Administration ('FDA') approved chronic myeloid leukemia treatment that was developed by Nanocopoeia, LLC. PHYRAGO is the first and only dasatinib product that can be co-administered with gastric acid-reducing agents. PHYRAGO was granted Orphan-Drug Designation and has received three (3) years of data exclusivity that will expire December 5, 2026. Should PHYRAGO be granted Orphan-Drug Exclusivity, it may be eligible for seven (7) years of exclusivity, until December 5, 2030. PHYRAGO is protected by several issued patents, including those listed in the FDA's Approved Drugs and Therapeutic Equivalents publication (the 'Orange Book') that expire January 22, 2041. The Company is in the process of selecting a U.S. commercialization partner and expects PHYRAGO to be available to patients in Q1-2025."

Commercial • Launch US • Orphan drug • Patent • B Acute Lymphoblastic Leukemia • Chronic Myeloid Leukemia