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SOUTH SAN FRANCISCO - The U.S. Food and Drug Administration has issued a Complete Response Letter rejecting Genentech’s application for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin for second-line treatment of diffuse large B-cell lymphoma (DLBCL). The news affects Genentech’s parent company Roche Group (SIX:RO, ROG; OTCQX:RHHBY), a pharmaceutical giant with a market capitalization of $271.5 billion and an impressive gross profit margin of 74.8%. According to InvestingPro analysis, Roche maintains a "GREAT" financial health score, suggesting strong resilience to market challenges.
In the letter, the FDA stated that data from the STARGLO study did not provide sufficient evidence to support the proposed indication for patients who are not candidates for autologous stem cell transplant.
The application was also intended to convert Columvi’s accelerated approval in third-line DLBCL to full approval. Columvi will maintain its accelerated approval for third-line or later DLBCL treatment in the U.S.
Genentech, a member of the Roche Group (SIX:RO, ROG; OTCQX:RHHBY), is in discussions with the FDA about using its Phase III SKYGLO study as a new postmarketing requirement. The SKYGLO study is investigating Columvi in combination with Polivy, Rituxan, and other medications for previously untreated large B-cell lymphoma.
The STARGLO study showed a 41% reduction in the risk of death for patients treated with the Columvi combination compared to standard therapy. Based on these results, the combination has been approved in more than 35 countries, including the European Union. This development adds to Roche’s robust revenue stream, which reached $68.8 billion in the last twelve months. InvestingPro data reveals that Roche has maintained dividend payments for 34 consecutive years, with 8.9% dividend growth in the latest period.
Jeremy Abramson, director of the Jon and Jo Ann Hagler Center for Lymphoma at Massachusetts General Hospital Cancer Center and principal investigator of the STARGLO study, noted that the regimen "significantly improves overall survival" for patients with this aggressive form of lymphoma.
Columvi monotherapy has been approved for use in relapsed/refractory DLBCL after two or more prior lines of therapy in more than 60 countries worldwide.
The information in this article is based on a press release statement from Genentech. For investors seeking deeper insights into Roche’s financial health and growth prospects, InvestingPro offers comprehensive analysis through its Pro Research Report, available for over 1,400 top stocks, including detailed metrics, expert analysis, and Fair Value assessments that help inform smarter investment decisions.
In other recent news, Genentech, part of the Roche Group, announced promising results from its Phase III SUNMO study. The study revealed that the combination of Lunsumio and Polivy significantly improved outcomes for patients with relapsed or refractory large B-cell lymphoma. The combination therapy achieved a median progression-free survival of 11.5 months, compared to 3.8 months for the control group, representing a 59% reduction in the risk of disease progression or death. Additionally, the objective response rate for this therapy was 70.3%, with a complete response rate of 51.4%. These results have been submitted to global health authorities, including the U.S. Food and Drug Administration, for approval consideration.
Meanwhile, Roche announced a substantial investment of up to $550 million in its Indianapolis diagnostics site, which will become a major hub for manufacturing continuous glucose monitoring systems. This expansion underscores Roche’s commitment to advancing healthcare innovation and is expected to create hundreds of skilled manufacturing jobs, along with thousands of construction jobs. The Indianapolis site, which already plays a crucial role in Roche’s operations, will enhance domestic production capabilities and decrease reliance on imports. This investment aligns with national efforts to bolster local manufacturing and improve access to innovative diabetes management solutions.
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