ZURICH (Reuters) - Novartis has been granted fast-track reviews of its cell therapy Kymriah for blood cancers in the United States and Europe, the Swiss drugmaker said on Wednesday, as it seeks to expand the pool of patients eligible for the costly treatment.
Kymriah, already approved for treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (ALL), will now get speedy scrutiny by the U.S. Food and Drug Administration for use against relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in adults, the company said in a statement.
In addition, the European Medicines Agency granted an accelerated assessment for Kymriah in children and young adults with ALL.
With priority review, the FDA’s goal is to make a decision on an application within six months instead of the normal 10 months. Europe’s accelerated review is similar, cutting the timeframe to 150 days from 210.
Kymriah belongs to a new class of treatments called CAR-T therapies where disease-fighting T cells are removed from a patient and genetically modified to better recognize and attack cancer. They are then re-infused into the same patient where they can circulate for years to seek out and fight the disease.
Novartis expects Kymriah will eventually top $1 billion in annual sales as it expands the patient pool eligible for the therapy, which for young patients with ALL costs $475,000 per treatment.
There is growing competition in the CAR-T space, with Gilead’s similar Yescarta approved for aggressive refractory adult lymphoma last October.
“The Priority Review designation and accelerated assessment signal that the FDA and EMA have recognized the potential of Kymriah to provide a much-needed therapeutic option for these patients,” said Samit Hirawat, who heads up Novartis Oncology Global Drug Development.
“We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients.”
Reporting by John Miller, editing by John Revill and Adrian Croft