資料來源：https://www.reuters.com/article/us-novartis-kymriah/novartis-seeks-european-approval-for-cell-therapy-kymriah-idUSKBN1D60JY

Swiss drugmaker Novartis has submitted its cell therapy Kymriah for European approval in two forms of blood cancer, seeking to expand the use of a new treatment it hopes will eventually become a $1 billion-a-year seller.

Novartis has applied to the European Medicines Agency (EMA) for Kymriah to be used in children and young adults with acute lymphoblastic leukemia (ALL) and adult patients with diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant, the company said on Monday.

The therapy has been approved in the United States in pediatric ALL and was submitted in the world’s largest drug market for adults with DLBCL last week.

The immunotherapy Kymriah is a key element of Novartis’s efforts to bolster its portfolio of oncology drugs. It has been hit by the patent expiry of its once top-selling blood cancer medicine Gleevec, whose market is quickly being eroded by generic rivals.

“The submission to the EMA is a major step toward our goal of delivering it to more critically ill cancer patients around the world,” said Vas Narasimhan, Novartis’s drug development chief who will take over as chief executive from Joe Jimenez on Feb. 1.

Kymriah is a chimeric antigen receptor T cell (CAR-T) therapy in which patients’ immune cells are taken from their bodies, genetically re-engineered to fight their cancer and then reinfused.

While Kymriah’s landmark approval in August in the United States signaled a new era in cancer treatment, the drug now faces rivals in the DLBCL setting. Last month, the U.S. Food and Drug Administration approved Gilead’s Yescarta for patients with the disease who had failed other treatments.

Novartis set the price for Kymriah at $475,000 per treatment for young patients with ALL that respond to the treatment, but the Basel-based company has yet to announce the price for additional indications and geographies.

Gilead charges $373,000 for Yescarta per patient.