Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Bristol, AstraZeneca Changes To IO Strategy Could Ultimately Be Regulatory Gain

Executive Summary

Bristol's filing of Yervoy/Opdivo in first-line lung cancer is delayed as the company drops its plans for accelerated approval, but could be on a more solid regulatory footing if the pivotal trial is successful. Meanwhile, AstraZeneca is using adaptive trial design to update MYSTIC, which could result in broader approvals.

You may also be interested in...



PD-1 Earnings Roundup: Buckle Up For A Bumpy Ride

Results from a number of Phase III studies in non-small cell lung cancer for major immuno-oncology players are coming soon, with potential to change the market dynamics.

Keytruda/Chemo Combo Approval Means Merck Holds Crown, For Now

FDA's approval of Merck's Keytruda/chemo combo based on Phase II data secures the company's position in the prized first-line lung cancer indication, but Phase III readouts from other combination trials are right around the corner.

Pfizer Takes Step Back With Avelumab, Step Forward On CAR-T

Major changes to Phase III Lung 100 study of PD-L1 inhibitor avelumab mean a big delay for development in first-line lung cancer, but, separately, Pfizer advances in allogeneic CAR-T therapy with partners Servier and Cellectis.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel