Adult Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients With Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy
Adult Lymphoblastic Lymphoma and the Philadelphia Chromosome Explained
ALL is an aggressive (fast-growing) type of leukemia (blood cancer) in which too many lymphoblasts (immature white blood cells) are found in the blood and bone marrow. Also called acute lymphoblastic leukemia and acute lymphocytic leukemia. The NCI estimates that there are 5,760 new cases each year of the disease and about 1,400 patients die each year as well. Sixty percent to 80% of adults with ALL can be expected to attain complete remission status following appropriate induction therapy. Approximately 35% to 40% of adults with ALL can be expected to survive 2 years with aggressive induction combination chemotherapy and effective supportive care during induction therapy (appropriate early treatment of infection, hyperuricemia, and bleeding).
A few studies, including a Cancer and Leukemia Group B study, that use intensive multiagent approaches suggest that a 50% 3-year survival is achievable in selected patients, but these results must be verified by other investigators.
Appropriate initial treatment, usually consisting of a regimen that includes the combination of vincristine, prednisone, and anthracycline, with or without asparaginase, results in a complete remission rate of up to 80%. Patients who experience a relapse after remission can be expected to succumb within 1 year, even if a second complete remission is achieved.
Talon Therapeutics, Inc has reached agreement with FDA regarding a special protocol assessment (SPA) for its planned Phase 3 study of Marqibo in adults with newly diagnosed Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).Talon submitted a NDA to the FDA in July 2011 seeking accelerated approval of Marqibo in adult Ph- ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy. The Phase 3 study now under SPA, named HALLMARQ (Halting newly diagnosed Adult acute Lymphoblastic Leukemia with Marqibo containing chemotherapy), is intended to be a confirmatory study to be completed following the accelerated approval of Marqibo.
Talon took the right path this time in trying to get Marqibo approved for this indication. Odds are very high for FDA approval but never a guarantee. If Advisory Panel turns this down,The Marqibo story is over>if Advisory gives a thumbs up,then odds are FDA approval will happen and totally changes dynamics of this company into a success story.
The committee will discuss New Drug Application (NDA) 202497, with the proposed trade name Marqibo (vincristine sulfate liposomes injection), application submitted by Talon Therapeutics, Incorporated. The proposed indication (use) for this product is for the treatment of adult patients with Philadelphia Chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of anti-leukemia therapy.