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Roche's (RHHBY) Cancer Drug Glofitamab Gets FDA Priority Review
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Roche Holding AG (RHHBY - Free Report) announced that the FDA accepted the biologics license application (BLA) seeking approval for its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, for treating adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
With the FDA granting a priority review to the BLA, a decision from the regulatory body on this novel cancer immunotherapy is expected on Jul 1, 2023.
If approved, glofitamab will become the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody to get the FDA nod for treating the most aggressive type of non-Hodgkin lymphoma.
The above-mentioned BLA was based on positive data from the pivotal phase I/II NP30179 study. Data from the same showed that treatment with glofitamab-induced durable response rates in people with heavily pre-treated large B-cell lymphoma, with 40% achieving a complete response.
In December 2022, Roche announced updated data for glofitamab in people with R/R LBCL at the annual meeting of the American Society of Hematology. The data suggest glofitamab has the potential to be the first off-the-shelf CD20xCD3 T-cell engaging bispecific antibody that can be given for a fixed period of time to people with heavily pre-treated aggressive lymphoma.
The FDA will review the glofitamab BLA under the granted Fast Track designation.
Shares of Roche have declined 24.8% in the past year against the industry’s growth of 15%.
Image Source: Zacks Investment Research
The ongoing phase III STARGLO study is evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with second-line plus diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.
Several studies are ongoing to investigate glofitamab as a monotherapy and in combination with other medicines for treating patients with B-cell NHLs, including DLBCL, mantle cell lymphoma and other blood cancers.
Upon potential approval, glofitamab is likely to diversify Roche’s lymphoma portfolio, which includes the newly approved lymphoma drug, Lunsumio (mosunetuzumab).
In December 2022, the FDA approved intravenously-administered Lunsumio for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have been treated with two or more lines of systemic therapy.
Lunsumio was approved by the regulatory agency under the accelerated pathway. Following approval, Lunsumio is the first CD20xCD3 T cell engaging bispecific antibody approved in the United States for the treatment of FL.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 7.2% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Celularity have narrowed 17.3% for 2023 in the past 60 days.
Earnings of Celularity surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. CELU witnessed an earnings surprise of 51.01% on average.
Loss per share estimates for Repare Therapeutics have narrowed 0.3% for 2023 in the past 60 days.
Earnings of Repare Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. RPTX witnessed an earnings surprise of 240.65% on average.
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Roche's (RHHBY) Cancer Drug Glofitamab Gets FDA Priority Review
Roche Holding AG (RHHBY - Free Report) announced that the FDA accepted the biologics license application (BLA) seeking approval for its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, for treating adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
With the FDA granting a priority review to the BLA, a decision from the regulatory body on this novel cancer immunotherapy is expected on Jul 1, 2023.
If approved, glofitamab will become the first fixed-duration CD20xCD3 T-cell engaging bispecific antibody to get the FDA nod for treating the most aggressive type of non-Hodgkin lymphoma.
The above-mentioned BLA was based on positive data from the pivotal phase I/II NP30179 study. Data from the same showed that treatment with glofitamab-induced durable response rates in people with heavily pre-treated large B-cell lymphoma, with 40% achieving a complete response.
In December 2022, Roche announced updated data for glofitamab in people with R/R LBCL at the annual meeting of the American Society of Hematology. The data suggest glofitamab has the potential to be the first off-the-shelf CD20xCD3 T-cell engaging bispecific antibody that can be given for a fixed period of time to people with heavily pre-treated aggressive lymphoma.
The FDA will review the glofitamab BLA under the granted Fast Track designation.
Shares of Roche have declined 24.8% in the past year against the industry’s growth of 15%.
Image Source: Zacks Investment Research
The ongoing phase III STARGLO study is evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with second-line plus diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.
Several studies are ongoing to investigate glofitamab as a monotherapy and in combination with other medicines for treating patients with B-cell NHLs, including DLBCL, mantle cell lymphoma and other blood cancers.
Upon potential approval, glofitamab is likely to diversify Roche’s lymphoma portfolio, which includes the newly approved lymphoma drug, Lunsumio (mosunetuzumab).
In December 2022, the FDA approved intravenously-administered Lunsumio for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have been treated with two or more lines of systemic therapy.
Lunsumio was approved by the regulatory agency under the accelerated pathway. Following approval, Lunsumio is the first CD20xCD3 T cell engaging bispecific antibody approved in the United States for the treatment of FL.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. (SNDX - Free Report) , Celularity Inc. (CELU - Free Report) and Repare Therapeutics Inc. (RPTX - Free Report) , all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 7.2% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Celularity have narrowed 17.3% for 2023 in the past 60 days.
Earnings of Celularity surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. CELU witnessed an earnings surprise of 51.01% on average.
Loss per share estimates for Repare Therapeutics have narrowed 0.3% for 2023 in the past 60 days.
Earnings of Repare Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. RPTX witnessed an earnings surprise of 240.65% on average.