FDA approval for nivolumab (Opdivo) for SCLC - 1295085

3 posts / 0 new
Last post
JimC
FDA approval for nivolumab (Opdivo) for SCLC - 1295085

An FDA press release states that:

"On August 16, 2018, the Food and Drug Administration granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company Inc.) for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy."

You can read more about this approval here: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm617370.htm...

Always good to have a new weapon in the fight against SCLC!

JimC
Forum moderator

onthemark
There is more good news for

There is more good news for SCLC that will be coming out soon in Toronto at the big conference there in September.

This is what Dr. West tweeted about this recent announcement

"H. Jack West, MD
‏Verified account
@JackWestMD
Aug 17
More H. Jack West, MD Retweeted OncLive.com
Puzzling for @US_FDA to approve nivo now for SCLC based on such not very timely & relatively modest data (both in terms of N & results) when phase III IMpower133 trial is being presented at WCLC in 1 mo & will show OS benefit w/1st line carbo/drop/atezolizumab. #LCSM ."

IMpower133: Atezolizumab in Combination With Chemotherapy in Previously Untreated, Extensive-Stage Small Cell Lung Cancer
By The ASCO Post
Posted: 7/3/2018 11:51:46 AM
Last Updated: 7/3/2018 1:00:36 PM

The study demonstrated that first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and etoposide) helped people with extensive-stage small cell lung cancer live significantly longer compared to chemotherapy alone. The atezolizumab-based combination improved progression-free survival (PFS) compared to chemotherapy alone. Safety for the atezolizumab and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming medical meeting.

http://www.ascopost.com/News/59020

“These are the first positive phase III survival results for any immunotherapy-based combination in the initial treatment of extensive-stage small cell lung cancer, a particularly difficult-to-treat type of disease,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development, Genentech. “The clinically meaningful results from the IMpower133 study add to the growing body of evidence demonstrating that atezolizumab-based combinations may be an effective treatment for different types of advanced lung cancer.

catdander
It sounds like Bristol-Myers

It sounds like Bristol-Myers Squibb Co may have pushed some buttons at fda to get opdivo on the list of alternatives for sclc even if 3 line, you know make a splash before the real splash of the better evidenced 1st line combo treatment of atezolizumab.