Rami Manochakian, Thoracic Medical Oncologist at Mayo Clinic Florida, shared on X:
“Hot off the press. Jazz Pharmaceuticals plans to ask U.S. FDA to withdraw:
Lurbinectedin (Zepzelca) approval in 2nd line Tx of Small Cell Lung Cancer (SCLC). This is based on Negative Lagoon phase 3 trial that showed NO OS benefit.”
Several oncologists shared this news on their X accounts.
Veli Bakalov, Hematologist and Oncologist at MD Anderson Cancer Center Copper։
“Here is a figure from all FDA approved drugs based on surrogate endpoints for ~20 years by Josh Elbaz, Alyson Haslam, and Vinay Prasad.
- 28% of surrogate approvals failed to show OS benefit
- 33% of surrogate approvals have yet to be tested for OS benefit
Only 7% were withdrawn from the market. Based on Jazz’s decision should other drugs be withdrawn?”
Razelle Kurzrock, Founding Director of the Michels Rare Cancers Research Laboratories:
“So does doing actual surgery just achieve plastic surgery on scans. And where are the RCT of surgery versus no surgery on early stage disease. ”
Drew Moghanaki, Nancy Stark Endowed Chair in Thoracic Radiation Oncology Research at David Geffen School of Medicine at UCLA:
“As a medical oncologist once taught me, treatments that improve response rates or PFS might achieve no more than ‘plastic surgery on the scans‘.”
You can also read:
LAGOON Trial: 3 Critical Results From Zepzelca in Second-Line SCLC