2022-07-07| Trials & Approvals

Roche’s Non-Hodgkin Lymphoma Drug Could See Accelerated Approval By December

by Reed Slater
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Swiss pharmaceutical giant Roche announced on July 6 that its relapsed or refractory follicular lymphoma (FL) drug, Lunsumio, received Priority Review from the FDA, which will decide on the drug’s Biologics License Application by December 29. If approved, Lunsumio could provide an alternative treatment for FL patients who have already received two or more previous therapies.


Providing More Options for FL Treatment


Follicular lymphoma is a type of non-Hodgkin’s lymphoma affecting white blood cells called lymphocytes, with about 15,000 cases yearly in the US. Roche designed Lunsumio to treat relapsed or refractory FL as a CD20xCD3 T-cell engaging bispecific antibody. The bispecific aspect of the name comes from targeting CD20 proteins on B cells and CD3 proteins on T cells. 

Roche’s Chief Medical Officer and Head of Global Product Development, Levi Garraway, M.D., Ph.D., explained, “New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns.”

The number of relapsed or refractory FL treatments has grown in the last year, with Novartis’ Kymriah gaining approval for the indication in May and Kite’s Yescarta in March 2021. The difference is that Kymriah and Yescarta are CAR T-cell therapies, an individualized therapy that alters a patient’s cells to help boost the immune system to fight cancer. 

Now, Roche’s bispecific technology is giving CAR T-cell treatments a run for their money without spending the time or money CAR T-cell therapies require. Garraway went on to say, “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 centre.”

The FDA will review Roche’s Lunsumio alongside Genentech’s, a subsidiary of Roche, mosunetuzumab. Lunsumio and mosunetuzumab are the same drugs, and the FDA’s decision in December will reflect both Roche’s product and Genentech’s. 

Related Article: Novartis CAR-T Cell Therapy Receives FDA Approval for Third Indication to Treat Follicular Lymphoma


Keeping Lunsumio’s Momentum Going


As it approaches its upcoming Biologics License Application decision date, Roche will continue putting Lunsumio to good use in the study, which will have considerable weight in the FDA’s decision. The GO29781 study, sponsored by Genentech, consists of 836 participants and has a primary endpoint of complete response rate and secondary endpoints of objective response rate, duration of response, progression-free survival, safety, and tolerability. 

If all goes well, the study will demonstrate positive results for the drug, justifying its success up to now. The FDA granted Lunsumio Orphan Drug Designation and later Breakthrough Therapy Designation in 2020. More recently, the European Commission granted Lunsumio conditional marketing authorization to treat relapsed or refractory FL. 

Roche hopes the December decision is not the final step for Lunsumio as it continues to develop the drug for more potential indications. The company says it is developing the drug as a monotherapy and in combination with other drugs to treat B-cell non-Hodgkin’s lymphomas, diffuse large B-cell lymphomas, and other blood cancers. 

For now, Roche will have to focus on Lunsumio’s potential approval as the first step before venturing into expanding territory. Come December, Roche’s competitors will know whether or not Lunsumio is as formidable of an opponent as Roche has touted it so far. 


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