Futures
Access hundreds of perpetual contracts
TradFi
Gold
One platform for global traditional assets
Options
Hot
Trade European-style vanilla options
Unified Account
Maximize your capital efficiency
Demo Trading
Futures Kickoff
Get prepared for your futures trading
Futures Events
Join events to earn rewards
Demo Trading
Use virtual funds to experience risk-free trading
Launch
CandyDrop
Collect candies to earn airdrops
Launchpool
Quick staking, earn potential new tokens
HODLer Airdrop
Hold GT and get massive airdrops for free
Launchpad
Be early to the next big token project
Alpha Points
Trade on-chain assets and earn airdrops
Futures Points
Earn futures points and claim airdrop rewards
FDA Accepts NDA for Exelixis' Zanzalintinib-Atezolizumab Combination
Exelixis has reached a significant regulatory milestone as the FDA greenlit its New Drug Application for a combination therapy targeting advanced colorectal cancer. The dual-agent approach pairs zanzalintinib, a tyrosine kinase inhibitor, with the immunotherapy atezolizumab—marking the company’s first NDA submission for this novel oncology candidate.
Regulatory Pathway and Treatment Eligibility
The FDA cleared the NDA for review under a standard timeline, with a PDUFA target action date set for December 3, 2026. This designation covers the treatment of adult patients with metastatic colorectal cancer who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Additionally, for patients with RAS wild-type tumors, prior anti-EGFR therapy is required.
Clinical Foundation and Development
The regulatory filing is underpinned by positive data from the phase 3 STELLAR-303 pivotal trial, which evaluated the combination therapy’s efficacy in this heavily pretreated patient population. Dana Aftab, Executive Vice President of Research and Development at Exelixis, stated the company’s readiness to work closely with the FDA throughout the review process for this landmark oncology NDA.
Market Response
Exelixis shares responded positively to the announcement, climbing 0.75% to $41.67 in pre-market trading on NasdaqGS, reflecting investor confidence in the company’s advancement in colorectal cancer therapeutics.