Novartis Withdraws Tislelizumab Submission
Pharma giant Novartis is no longer submitting tislelizumab following a delayed decision by the FDA. The PD-1 which had been licensed from BeiGene’s PD-1 inhibitor tislelizumab, in a deal worth up to 2.2 billion USD, has failed to impress.
Novartis first gained rights to tislelizumab outside of China earlier last year. They cited the therapy as being “complementary” to the checkpoint inhibiter spartalizumab, expecting it to play a key role in itheir PD-1/LI combination strategy.
The FDA's assessment showed that the data “didn’t adequately reflect the US population in terms of the number of patients and the standard of care that was used in that BeiGene-driven first-line study.”
Now Novartis has abandoned the monotherapy filing after receiving feedback form the FDA.
On Tuesday, the company announced that the FDA’s assessment showed that the data “didn’t adequately reflect the US population in terms of the number of patients and the standard of care that was used in that BeiGene-driven first-line study.”
- Recommended Approval for AbbVie’s Rinvoq Treatment
- AstraZeneca Buys T Cell Engager for $100 Million
- FDA Approves GSK’s MMR Vaccine
CEO of Novartis, Vas Narasimhan confirmed that the regulatory body made clear that all filed applications must be “global in nature, have an appropriate amount of US patients, and that the standard of care used reflects standard of care in the US.”
The decision came just months after the FDA rejected Eli Lilly and Innovent Biologics’ Tyvyt application, which likewise failed to meet trial diversity standards in PD-1 filings for non-small cell lung cancer.
Novartis is now committed to completing the filing for treatment for esophageal cancer.
Join Oxford Global‘s 2023 Biologics UK: In-Person event today. Happening in March, this 3-day conference brings together a panel of prominent leaders and scientists, sharing new case studies, innovative data, and exciting industry outlooks.
Keep up to date with the latest Industry Spotlight offerings at the Biologics Content Portal.
Related Resources
