Roche RHHBY announced that the FDA has granted Breakthrough Therapy designation (BTD) to its lymphoma drug Gazyva (obinutuzumab) for a new indication.
The agency granted BTD to the drug based on data from the phase II NOBILITY study in adult patients with proliferative lupus nephritis.
Lupus nephritis is a complication of systemic lupus erythematosus (SLE), which is an autoimmune disease, and a severe and potentially life-threatening disorder of the kidneys.
The study compared the safety and efficacy of Gazyva, combined with standard of care (mycophenolate mofetil [MMF] or mycophenolic acid [MPA] and corticosteroids), to placebo, combined with standard of care, in adult patients with ISN/RPS 2003 class III or IV proliferative lupus nephritis.
The study met its primary endpoint, which was the proportion of participants who achieved a protocol-defined complete renal response (CRR) at 52 weeks. Gazyva met key secondary endpoints as well.
Data from the study showed that Gazyva in combination with MMF or MPA and corticosteroids demonstrated enhanced efficacy compared to placebo plus standard of care in achieving CRR at one year in these patients.
BTD speeds up the development and review of drugs intended to treat serious or life-threatening conditions, with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies.
We note that Glaxo’s GSK Benlysta is currently approved for the treatment of SLE.
Roche plans to enroll patients in a phase III study next year. Gazyva is already approved for chronic lymphocytic leukemia (CLL) and previously-untreated advanced follicular lymphoma.
We note that Roche had a collaboration agreement with Biogen BIIB for Gazyva in the United States.
Meanwhile, combination studies evaluating Gazyva with other approved or investigational drugs, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.
Shares of Roche have gained 13.2% so far this year against the industry’s decline of 2.4%.
Roche’s immunology portfolio includes Actemra for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and giant cell arteritis (GCA); Rituxan for rheumatoid arthritis granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris (PV); Xolair for allergic asthma and chronic idiopathic urticaria (CIU); Pulmozyme for cystic fibrosis; and Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF). The company also has a deep pipeline, consisting of several candidates to treat immunological diseases, including autoimmune disorders, rheumatoid arthritis, ulcerative colitis and Crohn's disease.
Zacks Rank & Another Stock to Consider
Roche currently carries a Zacks Rank #2 (Buy).
Another well-placed, large-cap pharma stock is Bristol-Myers Squibb Company BMY, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $4.16 to $4.29 for 2019 and from $5.74 to $5.36 for 2020 in the past 60 days.
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