Bristol nabs Opdivo 'breakthrough' in bladder cancer--and gears up for Roche showdown


Roche’s brand-new immuno-oncology med Tecentriq currently has the bladder cancer market all to itself--but that's not going to last long.

Monday, Bristol-Myers Squibb's Opdivo nabbed a “breakthrough” tag from U.S. regulators, who will now speedily review the med for use in patients with advanced bladder cancer who have failed on platinum-based chemotherapy.

That’s the same indication for which Roche snagged an FDA green light when it ushered Tecentriq onto the scene in May, and any regulatory success for Bristol will compromise Tecentriq’s position as the only checkpoint inhibitor in the bladder cancer market.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

But of course, Roche isn’t shying away from its rivals Opdivo and Merck's Keytruda. Back in April, the FDA granted Tecentriq a priority review in lung cancer, putting it in line for a quick thumbs up.

Lung cancer was the second battleground for Opdivo and Keytruda after the pair first established their presence in the melanoma field, and the meds’ makers have been racing to get ahead through winning additional indications, moving into earlier lines of therapy, and grabbing approval in new locations.

On that front, Keytruda got its own boost Monday thanks to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which recommended the product as a treatment for patients with advanced NSCLC who have gone through one or more chemo regimens.

- read Bristol's release
- read Merck's release

Related Articles:
Roche's Tecentriq bursts onto immuno-oncology scene, with Merck and BMS in its sights
Roche's atezo gets FDA fast track, BMS, Merck showdown coming
Merck's Keytruda held back by docs who don't want to wait for diagnostics
Roche's atezo lines up PD-L1 data for forthcoming battle with Keytruda, Opdivo


Suggested Articles

An injection that's under FDA priority review as a monthly HIV therapy can suppress the virus even if given every two months, a phase 3 has shown.

Pfizer and Astellas are chasing a new nod for prostate cancer drug Xtandi, and thanks to the FDA, they might not have to wait that long.

Sanofi lost an appeal challenging the ban on its dengue vaccine Dengvaxia in the Philippines, despite an ongoing outbreak there.