FDA grants revolutionary therapy CTL019 Novartis for the treatment / refractory ALL -
Breakthrough Therapy Novartis announced today that the US Food and Drug Administration (FDA) has granted a status relapse CTL019, a chimeric antigen receptor (CAR) investigational therapy for the treatment of pediatric and adult patients with relapsed / refractory acute lymphoblastic leukemia (r / r ALL). The filing of the revolutionary therapy was presented by the University of Pennsylvania Perelman School in Medicine (Penn), which entered into an exclusive worldwide agreement with Novartis for the research, development and commercialization of personalized CAR T cell therapies for cancer treatment.
This is the fifth breakthrough therapy designation for Novartis, continuing the trajectory of the company as a leader in the development of innovative therapies to help treat diseases in which there is significant non-medical needs satisfied. Novartis Zykadia ( ™ ) (ceritinib, previously known as LDK378), for the treatment of anaplastic lymphoma positive kinase (ALK +) non-small cancer metastatic lung (NSCLC) is one of the first drug to receive FDA approval earlier after receiving the designation of the breakthrough therapy by the FDA.
"This designation revolutionary therapy highlights the potential of CTL019 as salvage therapy for patients with relapsed / refractory ALL, who are in desperate need of new treatment options," said David Epstein, Head division, Novartis Pharmaceuticals. "Novartis welcomes enhanced dialogue with the FDA and a potentially accelerated review in order to streamline the development CTL019 and we hope to bring this promising therapy to patients as quickly as possible."
According FDA designation of Breakthrough therapy is intended to accelerate the development and review of new drugs that treat serious or life-threatening conditions if the therapy has demonstrated a substantial improvement over an available therapy on at least one parameter clinically significant. the designation includes all the features of the fast track program and more intensive FDA guidelines. There is a separate status to both the approval and priority of parole review, which may also be granted to the same drug if the relevant criteria are met.
"This is an important step that we are now a step further by helping address the unmet needs of this patient population," said H. Carl June, MD, Professor Richard W. immunotherapy Wave in the department of pathology and laboratory medicine at the Perelman school of medicine and Director of translational research at the Abramson Cancer Center of the University of Pennsylvania. "We are thrilled to force the first positive data observed in pediatric and adult patients with relapsed / refractory acute lymphoblastic leukemia and look forward to building on these results as we continue advancing the clinical program CTL019 in Phase II trials. "
Novartis recently created cell and Gene therapies Unit led by Usman Azam, global head, to bring an intense focus on the advancement of therapies based on innovative cells, including the development of the CARs. Novartis owns the worldwide rights of RAC developed through collaboration with Penn for all cancer indications, including the main program, CTL019.
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