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Roche’s bispecific antibody Lunsumio wins priority review from FDA for non-Hodgkin lymphoma

By Brian Buntz | July 6, 2022

Roche in Drug Discovery & Development Pharma 50Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced that it has accepted the company’s Biologics License Application (BLA) and granted priority review for Lunsumio (mosunetuzumab), a CD20xCD3 T-cell engaging bispecific antibody developed by the company’s Genentech subsidiary.

In February, Biogen (Nasdaq:BIIB) said it would pay $30 million to exercise an option to participate in the development and commercialization of the drug candidate.

Basel, Switzerland-based Roche believes mosunetuzumab holds potential for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two other systemic therapies.

Follicular lymphoma arises from B-lymphocytes and is a common slow-growing form of non-Hodgkin lymphoma (NHL).

Approximately one in five patients with follicular lymphoma relapse within two years of diagnosis, according to an article in the ASCO Post.

Lunsumio would be a fixed-duration treatment that could potentially be administered in an outpatient setting.

FDA anticipates making a decision on mosunetuzumab by 29 December 2022

“New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns. Clinical trial results have demonstrated durable responses with Lunsumio in advanced follicular lymphoma, representing a step toward shifting the treatment paradigm,” said Dr. Levi Garraway, Roche’s chief medical officer and head of global product development. “Since Lunsumio does not require the collection or genetic modification of patient cells, it could become an effective, fixed-duration outpatient option without the barriers of traveling to a major academic center,” Garray added in a news release.

The priority review was based on data from a pivotal Phase 1/2 trial that associated Lunsumio with high and durable complete response rates in previously treated follicular lymphoma.


Filed Under: clinical trials, Drug Discovery, Oncology
Tagged With: Lunsumio, mosunetuzumab, NHL, non-Hodgkin lymphoma, Roche
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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