12. Gazyva


Product: Gazyva
Generic name: obinutuzumab
Company: Roche
2015 sales: $133 million
2022 sales: $3.43 billion
Current indications: chronic lymphocytic leukemia; follicular lymphoma

Roche is relying on Gazyva to defend its position in the treatment of several blood cancers when big-selling Rituxan begins to face competition from biosimilars, possibly as early as 2017. The drug is billed as a new-and-improved version of Rituxan, with the same anti-CD20 mechanism of action. Like its parent, it is being developed for an array of B cell malignancies.

First approved in 2013 to treat people with previously untreated chronic lymphocytic leukemia (CLL), Gazyva initially saw sluggish growth. After picking up a second approval in follicular lymphoma (FL), sales picked up, and Roche's plans started to look more secure. That is, until Gazyva failed to best Rituxan when added to chemotherapy in previously untreated patients with diffuse large B-cell lymphoma in the GOYA trial. That failure—admittedly in an aggressive form of non-Hodgkin lymphoma (NHL)—could make it harder for Gazyva to capture market share from its tried-and-tested predecessor.

As for FL—the most common form of slow-growing NHL—Gazyva is currently approved for second-line use after Rituxan relapse based on the results of the GADOLIN trial. Roche also says Gazyva performed better than Rituxan in the head-to-head GALLIUM trial, improving progression-free survival, setting it up to enter the far-larger first-line market.

All eyes were on the data presented at the American Society of Hematology congress in early December 2016. In that trial, Roche said Gazyva, when tested alongside chemotherapy, trumped Rituxan in FL patients who hadn’t been treated previously. In the meantime, Roche reckons it has other opportunities to grow Gazyva. It has trials in progress in acute myeloid leukemia, multiple myeloma and mesothelioma, as well as combination trials with AbbVie-partnered Venclexta in CLL.

12. Gazyva