Dive Brief:
- Bristol-Myers Squibb Co. announced Tuesday morning the Food and Drug Administration gave its blockbuster PD-1 inhibitor Opdivo an OK for a new dosing schedule.
- Opdivo is now the first PD-1/L1 approved for an every four-week dosing schedule, according to the company. The FDA also green lighted a shorter infusion time of just 30 minutes for the drug.
- The label update gives patients and their physicians the choice of a 240 mg flat dose every two weeks or 480 mg every four weeks for most of Opdivo's already approved indications.
Dive Insight:
While a change in the dosing schedule might not seem like a game-changer, it absolutely could be.
The immuno-oncology space has become increasingly crowded since Bristol-Myers' Opdivo (nivolumab) and Merck & Co.'s Keytruda (pembrolizumab) hit the market in 2014. There are now multiple other heavy-hitters in the space, with offerings from Roche AG, AstraZeneca plc and Pfizer Inc., and others in the pipeline, including an offering from Sanofi SA and Regeneron Pharmaceuticals Inc.
Opdivo continues to dominate by revenue, while Merck's Keytruda has been wracking up more indications. With the approval of Keytruda in first-line lung cancer, the Merck drug is now threatening Opdivo's sales lead.
The checkpoint inhibitors as a class of drugs have shown little differentiation between therapies. Aside from first-line lung cancer, Opdivo and Keytruda largely have the same swath of indications under their belts.
This new dosing schedule will be a key differentiating point. (Immuno-oncology companies are also studying these drugs as combination therapies with other classes to find further differentiation and personalization for cancer regimens.)
The move from Bristol-Myers to seek a more flexible dosing schedule for Opdivo could be an attractive option from the physician and patient perspective. Patients often have to travel long distances to go to infusion centers and need to arrange other things like missing work or childcare. Infusion centers are also often overcrowded.