Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews

Executive Summary

Oncologic Drugs Advisory Committee was swayed by views of its disease area experts in favorably reporting out Geron’s imetelstat for myelodysplastic syndromes and supplemental applications for the CAR-T products Carvykti and Abecma in earlier lines of multiple myeloma.

You may also be interested in...

US FDA’s April Outlook: Decisions Pending For Rare Pediatric Diseases, New Antibiotics

User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts

Oncologic Drugs Advisory Committee reps and the Oncology Center of Excellence director go behind the scenes to discuss FDA interactions with panelists, how opinions can change during a meeting, and why the voting question is important.

Applications Heavily Reliant On Foreign Data Get Positive Signals In US FDA Reviews

Agency has notably rejected some NDAs that relied solely on Chinese data, but a positive advisory committee for Geron’s proposed anemia treatment imetelstat and approval for BeiGene’s anti-PD-1 antibody Tevimbra suggest that using a lot of foreign data could be OK.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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