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AbbVie (ABBV) Gets CHMP Nod for Lymphoma Drug's Expanded Use
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AbbVie (ABBV - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending granting conditional marketing authorization for the expanded use of its drug Tepkinly (epcoritamab) for treating relapsed/refractory follicular lymphoma (R/R FL).
AbbVie is seeking approval for Tepkinly in the EU as a monotherapy for the treatment of adult patients with R/R FL after two or more prior therapies. The European Commission’s decision is expected later this year.
Tepkinly, which is marketed as Epkinly in the United States, was approved by the FDA on an accelerated basis for the FL indication last week. Epkinly/Tepkinly was approved for relapsed-refractory third-line diffuse large B-cell lymphoma (DLBCL) in 2023.
If approved for the FL indication, Tepkinly will become the first and only bispecific antibody conditionally approved as a monotherapy in the EU to treat both R/R FL and R/R DLBCL after two or more lines of prior therapy.
Year to date, AbbVie’s stock has risen 10.7% compared with a rise of 21.1% for the industry.
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.
The CHMP nod and FDA’s approval for the FL indication were based on data from the FL cohort of the phase I/II EPCORE NHL-1 study. Data from the study showed that patients who were treated with the drug achieved an overall response rate of 82%, including a complete response rate of 60%.
Epkinly/Tepkinly has been developed by AbbVie in collaboration with Genmab (GMAB - Free Report) 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’s share of profit from U.S. revenues of Epkinly and product revenues for Tepkinly from international markets were $27 million in the first quarter of 2024.
AbbVie and Genmab are also evaluating Epkinly both as a monotherapy and as a combination regimen across lines of therapy in a range of hematologic malignancies.
On Jun 28, the CHMP also recommended approving Merck’s (MRK - Free Report) pulmonary arterial hypertension (PAH) drug Winrevair (sotatercept) in Europe. The decision of the European Commission is expected in the third quarter of 2024. If approved by the European Commission, Merck’s Winrevair will become the first activin signaling inhibitor therapy for PAH in Europe. Winrevair (sotatercept) was approved for pulmonary arterial hypertension in March 2024. Merck expects Winrevair to generate significant revenues over the long term.
The CHMP also gave a positive opinion for the approval of J&J’s (JNJ - Free Report) Balversa (erdafitinib) for treating unresectable or metastatic urothelial carcinoma (UC) in adult patients who have FGFR alterations. UC is the most common form of bladder cancer. The CHMP opinion was based on data from the THOR study. J&J’s Balversa is already approved for treating FGFR-altered locally-advanced or metastatic UC in the United States. J&J had submitted the marketing authorization seeking approval of Balversa in the EU in September last year.
Image: Bigstock
AbbVie (ABBV) Gets CHMP Nod for Lymphoma Drug's Expanded Use
AbbVie (ABBV - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending granting conditional marketing authorization for the expanded use of its drug Tepkinly (epcoritamab) for treating relapsed/refractory follicular lymphoma (R/R FL).
AbbVie is seeking approval for Tepkinly in the EU as a monotherapy for the treatment of adult patients with R/R FL after two or more prior therapies. The European Commission’s decision is expected later this year.
Tepkinly, which is marketed as Epkinly in the United States, was approved by the FDA on an accelerated basis for the FL indication last week. Epkinly/Tepkinly was approved for relapsed-refractory third-line diffuse large B-cell lymphoma (DLBCL) in 2023.
If approved for the FL indication, Tepkinly will become the first and only bispecific antibody conditionally approved as a monotherapy in the EU to treat both R/R FL and R/R DLBCL after two or more lines of prior therapy.
Year to date, AbbVie’s stock has risen 10.7% compared with a rise of 21.1% for the industry.
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.
The CHMP nod and FDA’s approval for the FL indication were based on data from the FL cohort of the phase I/II EPCORE NHL-1 study. Data from the study showed that patients who were treated with the drug achieved an overall response rate of 82%, including a complete response rate of 60%.
Epkinly/Tepkinly has been developed by AbbVie in collaboration with Genmab (GMAB - Free Report) 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’s share of profit from U.S. revenues of Epkinly and product revenues for Tepkinly from international markets were $27 million in the first quarter of 2024.
AbbVie and Genmab are also evaluating Epkinly both as a monotherapy and as a combination regimen across lines of therapy in a range of hematologic malignancies.
On Jun 28, the CHMP also recommended approving Merck’s (MRK - Free Report) pulmonary arterial hypertension (PAH) drug Winrevair (sotatercept) in Europe. The decision of the European Commission is expected in the third quarter of 2024. If approved by the European Commission, Merck’s Winrevair will become the first activin signaling inhibitor therapy for PAH in Europe. Winrevair (sotatercept) was approved for pulmonary arterial hypertension in March 2024. Merck expects Winrevair to generate significant revenues over the long term.
The CHMP also gave a positive opinion for the approval of J&J’s (JNJ - Free Report) Balversa (erdafitinib) for treating unresectable or metastatic urothelial carcinoma (UC) in adult patients who have FGFR alterations. UC is the most common form of bladder cancer. The CHMP opinion was based on data from the THOR study. J&J’s Balversa is already approved for treating FGFR-altered locally-advanced or metastatic UC in the United States. J&J had submitted the marketing authorization seeking approval of Balversa in the EU in September last year.
Zacks Rank
AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.