- Bristol-Myers Squibb (NYSE:BMY) and Novartis (NYSE:NVS) have obtained the U.S. regulatory approval to sell their cancer medications, Opdivo and Kymriah, for additional indications in esophageal cancer and blood cancer, respectively.
- Accordingly, Opdivo, known as nivolumab in generic terms, is allowed as a first-line option to treat adults with unresectable esophageal squamous cell carcinoma regardless of the PD-L1 expression in tumors.
- The FDA has greenlighted two Opdivo-containing regimens for the indication: Opdivo with fluoropyrimidine and platinum-containing chemotherapy as well as Opdivo plus Yervoy.
- The approval was based on data from a late-stage trial called CheckMate -648 in which Opdivo in combination with Chemotherapy and Opdivo plus Yervoy outperformed chemotherapy alone.
- Currently, Opdivo-based regimens are allowed in five indications in upper gastroesophageal cancers.
- Meanwhile, Novartis (NVS) said that the FDA granted accelerated approval for Kymriah for adults with relapsed or refractory follicular lymphoma as a third-line option following at least two systemic treatments.
- With the latest regulatory nod, Kymriah (tisagenlecleucel) is approved for three blood cancer types in the U.S. The CAR-T cell therapy generated $587M net sales in 2021 with ~24% YoY growth.
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