Novartis on Monday said that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications.
The application is for the treatment of children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer.
Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis, said: “Since the historic FDA approval of Kymriah, formerly CTL019, we have launched, manufactured and supplied this highly individualized immunocelluar therapy in a commercial setting and the submission to the EMA is a major step toward our goal of delivering it to more critically ill cancer patients around the world. We look forward to working with the EMA to make CTL019 available to the children and adults who may benefit from this novel therapy.”
This submission brings Novartis closer to realizing potential for more patients with fatal blood cancers. The study’s principal investigator Stephen J. Schuster, said: “When tisagenlecleucel became a reality for certain patients and their families in the US after approval by the FDA for patients with relapsed or refractory ALL this year, I believe it forever changed the face of cancer treatment. The data show this is a groundbreaking immunocellular therapy that has the potential to alter outcomes in patients who have limited options. “
In its other announcement on Monday, Novartis said that its new long-term Cosentyx data for patients with ankylosing spondylitis show that almost 80 percent of AS patients treated with Cosentyx have no radiographic progression (mSASSS <2) of the spine at 4 years. The new data also confirm sustained improvement in signs and symptoms in almost 80 percent of patients, while Cosentyx delivers a favorable and consistent safety profile.
“The key finding of these data is that patients treated with Cosentyx may now have the opportunity to maintain their mobility for a longer time. This is very important as ankylosing spondylitis is a crippling condition that can impact people in their twenties when they still have many decades of their life ahead of them,” said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. “For the first time for any biologic, Cosentyx shows that almost 80 percent of patients had no radiographic progression for as long as 4 years. These data demonstrate the potential of Cosentyx to help patients live with less pain and retain their mobility for longer”.