Oxford BioMedica PLC (OXBDF)

[marcusl2]

Bingo, great news

Novartis gets second CAR-T candidate FDA ‘breakthrough’ tag

This latest label, which can speed things along for Novartis’ CTL019 (tisagenlecleucel), is for relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). This is the most common form of lymphoma and accounts for around 30% of all non-Hodgkin lymphoma cases.

Novartis says its latest breakthrough designation is based on highly-anticipated data from its phase 2 JULIET study, which is looking at the efficacy and safety of CTL019 in adult patients with r/r DLBCL.

Investors have been chomping at the bit for the JULIET data, but Novartis only said they “are expected to be presented at an upcoming medical congress.” Kite Pharma and its investors will also be keen to see how well, or not, the JULIET data turns out to be.

“At Novartis, we are eager to unlock the full potential of CTL019, including the potential to help patients with r/r DLBCL,” said Vas Narasimhan, global head of drug development and CMO at Novartis.

“We look forward to working closely with the FDA to help bring this potential new treatment option to patients as soon as possible.”

If Novartis does turn victor in the race to market, this will come as a major turnaround given that last year, it announced plans to cut back on its gene and cell therapy unit (which developed this drug) and saw the exodus of many of those who had helped create and nurture it.

HTTP://www.fiercebiotech.com/biotech/novartis-gets-second-car-t-candidate-fda-breakthrough-tag