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Roche (RHHBY) Gets FDA Approval for Blood Cancer Drug Columvi
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Roche (RHHBY - Free Report) announced that the FDA granted accelerated approval to Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma after two or more lines of systemic therapy.
Columvi is a CD20xCD3 T-cell-engaging bispecific antibody.
The accelerated approval was based on response rate and durability of response in phase I/II NP30179 study, wherein Columvi was given as a fixed course for 8.5 months in 132 patients with DLBCL who had relapsed or were refractory to prior therapies, including about 30% who had received prior CAR T-cell therapy. Among these, 83% were refractory to their most recent therapy. Data showed that patients treated with fixed-duration Columvi achieved durable remission, with 56% of patients achieving an overall response and 43% of patients achieving a complete response. Over two-thirds of those who responded continued to respond for at least nine months. The median duration of response was 1.5 years.
The continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.
The drug is already approved in Canada for the treatment of adults with relapsed or refractory DLBCL.
In April 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Columvi for the treatment of adult patients with R/R DLBCL after two or more lines of systemic therapy.
DLBCL, the most common form of non-Hodgkin’s lymphoma (NHL) in the United States, is an aggressive blood cancer.
Roche’s stock has gained 0.1% in the year so far compared with the industry’s growth of 2%.
Image Source: Zacks Investment Research
Roche’s Genentech is evaluating Columvi in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with DLBCL who have been treated with one or more previous therapies and are ineligible for autologous stem cell transplant in the late-stage STARGLO study.
The bispecific antibody portfolio also includes Lunsumio (mosunetuzumab-axgb), which was granted accelerated approval by the FDA in December 2022 for the treatment of adult patients with R/R follicular lymphoma after two or more lines of systemic therapy.
Genentech is evaluating both Columvi and Lunsumio as monotherapies and in combination with other therapies, including Polivy (polatuzumab vedotin-piiq), in earlier lines of treatment to provide patients with long-lasting outcomes. The program includes two phase III studies: CELESTIMO, evaluating Lunsumio plus Revlimid in second-line plus (2L+) FL and SUNMO, investigating evaluating plus Polivy in 2L+ DLBCL. Polivy is also approved for DLBCL.
Approval of new drugs bodes well for Roche, which boasts a strong oncology portfolio.
Roche’s performance in the first quarter was ordinary, as significantly lower COVID-19 product sales impacted the top line. However, new drugs — Ocrevus, Hemlibra, Evrysdi and Tecentriq — recorded growth and the uptake of the new eye drug, Vabysmo (launched at the beginning of 2022), was outstanding.
Sales are likely to be impacted further due to the expected sharp decline in sales of COVID-19 products of roughly CHF 5 billion in 2023. Competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin also harmed sales.
Over the past 30 days, earnings estimates for LGND have increased by 46 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.72 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Roche (RHHBY) Gets FDA Approval for Blood Cancer Drug Columvi
Roche (RHHBY - Free Report) announced that the FDA granted accelerated approval to Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma after two or more lines of systemic therapy.
Columvi is a CD20xCD3 T-cell-engaging bispecific antibody.
The accelerated approval was based on response rate and durability of response in phase I/II NP30179 study, wherein Columvi was given as a fixed course for 8.5 months in 132 patients with DLBCL who had relapsed or were refractory to prior therapies, including about 30% who had received prior CAR T-cell therapy. Among these, 83% were refractory to their most recent therapy. Data showed that patients treated with fixed-duration Columvi achieved durable remission, with 56% of patients achieving an overall response and 43% of patients achieving a complete response. Over two-thirds of those who responded continued to respond for at least nine months.
The median duration of response was 1.5 years.
The continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.
The drug is already approved in Canada for the treatment of adults with relapsed or refractory DLBCL.
In April 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Columvi for the treatment of adult patients with R/R DLBCL after two or more lines of systemic therapy.
DLBCL, the most common form of non-Hodgkin’s lymphoma (NHL) in the United States, is an aggressive blood cancer.
Roche’s stock has gained 0.1% in the year so far compared with the industry’s growth of 2%.
Image Source: Zacks Investment Research
Roche’s Genentech is evaluating Columvi in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with DLBCL who have been treated with one or more previous therapies and are ineligible for autologous stem cell transplant in the late-stage STARGLO study.
The bispecific antibody portfolio also includes Lunsumio (mosunetuzumab-axgb), which was granted accelerated approval by the FDA in December 2022 for the treatment of adult patients with R/R follicular lymphoma after two or more lines of systemic therapy.
Genentech is evaluating both Columvi and Lunsumio as monotherapies and in combination with other therapies, including Polivy (polatuzumab vedotin-piiq), in earlier lines of treatment to provide patients with long-lasting outcomes. The program includes two phase III studies: CELESTIMO, evaluating Lunsumio plus Revlimid in second-line plus (2L+) FL and SUNMO, investigating evaluating plus Polivy in 2L+ DLBCL. Polivy is also approved for DLBCL.
Approval of new drugs bodes well for Roche, which boasts a strong oncology portfolio.
Roche’s performance in the first quarter was ordinary, as significantly lower COVID-19 product sales impacted the top line. However, new drugs — Ocrevus, Hemlibra, Evrysdi and Tecentriq — recorded growth and the uptake of the new eye drug, Vabysmo (launched at the beginning of 2022), was outstanding.
Sales are likely to be impacted further due to the expected sharp decline in sales of COVID-19 products of roughly CHF 5 billion in 2023. Competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin also harmed sales.
Zacks Rank & Other Stocks to Consider
Roche currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . While Ligand sports a Zacks Rank #1 (Strong Buy), NVS carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by 46 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.72 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.