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.


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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


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