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AbbVie (ABBV) Lymphoma Drug Gets FDA Breakthrough Therapy Tag
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AbbVie (ABBV - Free Report) along with partner Genmab (GMAB - Free Report) announcedthat the FDA has granted breakthrough therapy designation (“BTD”) to epcoritamab for treating adults with relapsed or refractory (“R/R”) follicular lymphoma (“FL”), after two or more lines of therapies.
The FDA grants BTD to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments.
Alongside the above news, AbbVie and Genmab also announced that the European Medicines Agency (“EMA”) has validated a regulatory filing for epcoritamab in the same indication. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union.
Epcoritamab received accelerated approval from the FDA in May to treat R/R diffuse large B-cell lymphoma (“DLBCL”). The drug is being marketed under the trade name Epkinly. In September, the drug received was granted conditional approval in the European Union for a similar indication under the trade name Tepkinly.
The BTD and EMA filing validation were supported by data from the FL cohort of the phase I/II EPCORE NHL-1 study. Data from the study, previously reported in June, showed that patients who were treated with epcoritamab demonstrated an overall response rate of 82%, with the median duration of response yet to be reached.
Year to date, shares of AbbVie have declined 13.9% against the industry‘s 5.7% rise.
Image Source: Zacks Investment Research
FL is the most common form of indolent or slow-growing form of non-Hodgkin's lymphoma (“NHL”), while DLBCL is the most common form of aggressive or fast-growing form of NHL.
Epcoritamab is being developed by AbbVie in collaboration with Genmab as part of an oncology collaboration deal signed in 2020 to jointly develop and market three of the latter’s early-stage investigational bispecific antibody product candidates.
Per the terms of the collaboration deal, AbbVie and Genmab share commercial responsibilities for epcoritamab in the United States and Japan. AbbVie is responsible for global commercialization.
AbbVie and Genmab are evaluating epcoritamab both as a monotherapy and as a combination regimen across lines of therapy in a range of hematologic malignancies. This includes three late-stage studies — a monotherapy study in patients with R/R DLBCL and two combination studies evaluating epcoritamab combination therapies in patients with newly diagnosed DLBCL and R/R FL.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.22 to $2.62. During the same period, the earnings estimates per share for 2024 have risen from $2.57 to $3.07. Shares of NVO have surged 53.5% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have increased from 67 cents to 72 cents. During the same period, the earnings estimates per share for 2024 have risen from 55 cents to 62 cents. Shares of PBYI have risen 6.2% in the year-to-date period.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an average surprise of 76.55%. In the last reported quarter, Puma Biotechnology’s earnings beat estimates by 13.33%.
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AbbVie (ABBV) Lymphoma Drug Gets FDA Breakthrough Therapy Tag
AbbVie (ABBV - Free Report) along with partner Genmab (GMAB - Free Report) announcedthat the FDA has granted breakthrough therapy designation (“BTD”) to epcoritamab for treating adults with relapsed or refractory (“R/R”) follicular lymphoma (“FL”), after two or more lines of therapies.
The FDA grants BTD to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments.
Alongside the above news, AbbVie and Genmab also announced that the European Medicines Agency (“EMA”) has validated a regulatory filing for epcoritamab in the same indication. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union.
Epcoritamab received accelerated approval from the FDA in May to treat R/R diffuse large B-cell lymphoma (“DLBCL”). The drug is being marketed under the trade name Epkinly. In September, the drug received was granted conditional approval in the European Union for a similar indication under the trade name Tepkinly.
The BTD and EMA filing validation were supported by data from the FL cohort of the phase I/II EPCORE NHL-1 study. Data from the study, previously reported in June, showed that patients who were treated with epcoritamab demonstrated an overall response rate of 82%, with the median duration of response yet to be reached.
Year to date, shares of AbbVie have declined 13.9% against the industry‘s 5.7% rise.
Image Source: Zacks Investment Research
FL is the most common form of indolent or slow-growing form of non-Hodgkin's lymphoma (“NHL”), while DLBCL is the most common form of aggressive or fast-growing form of NHL.
Epcoritamab is being developed by AbbVie in collaboration with Genmab as part of an oncology collaboration deal signed in 2020 to jointly develop and market three of the latter’s early-stage investigational bispecific antibody product candidates.
Per the terms of the collaboration deal, AbbVie and Genmab share commercial responsibilities for epcoritamab in the United States and Japan. AbbVie is responsible for global commercialization.
AbbVie and Genmab are evaluating epcoritamab both as a monotherapy and as a combination regimen across lines of therapy in a range of hematologic malignancies. This includes three late-stage studies — a monotherapy study in patients with R/R DLBCL and two combination studies evaluating epcoritamab combination therapies in patients with newly diagnosed DLBCL and R/R FL.
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Novo Nordisk (NVO - Free Report) and Puma Biotechnology (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.22 to $2.62. During the same period, the earnings estimates per share for 2024 have risen from $2.57 to $3.07. Shares of NVO have surged 53.5% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have increased from 67 cents to 72 cents. During the same period, the earnings estimates per share for 2024 have risen from 55 cents to 62 cents. Shares of PBYI have risen 6.2% in the year-to-date period.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an average surprise of 76.55%. In the last reported quarter, Puma Biotechnology’s earnings beat estimates by 13.33%.