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AbbVie (ABBV) BLA for Epcoritamab Gets FDA Priority Tag

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AbbVie (ABBV - Free Report) and partner Genmab (GMAB - Free Report) announced that the FDA has accepted and granted priority review to its biologics license application (BLA) seeking approval for epcoritamab for the treatment of relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. LBCL is a common form of non-Hodgkin's lymphoma (NHL). 

Genmab had filed the BLA for epcoritamab, a subcutaneous bispecific antibody, in October. In the EU too, a marketing authorization application (MAA) seeking approval for epcoritamab for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) – a major subtype of LBCL – after two or more lines of systemic therapy, was validated by the European Medicines Agency in October.

The BLA is supported by data from the LBCL cohort of phase I/II study, EPCORE NHL-1 evaluating subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL, including LBCL. Previously announced top-line data from the LBCL cohort demonstrated a confirmed overall response rate (ORR) of 63.1%, while the median duration of response (DOR) was 12 months.

AbbVie’s stock has risen 16.0% this year so far compared with an increase of 6.3% for the industry.


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AbbVie and Genmab announced an oncology collaboration deal in 2020 to jointly develop and market three of the latter’s early-stage investigational bispecific antibody product candidates, which included epcoritamab. AbbVie and Genmab share commercial responsibilities for epcoritamab in the United States and Japan, while the former is responsible for further 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. Some ongoing studies are a phase III study on epcoritamab as a monotherapy in patients with relapsed/refractory DLBCL and another one evaluating epcoritamab in combination in patients with relapsed/refractory follicular lymphoma.

Zacks Rank & Stock to Consider

AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked large drugmakers are Vertex Pharmaceuticals (VRTX - Free Report) and Merck (MRK - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vertex Pharmaceuticals’ stock has risen 44.0% this year. Estimates for Vertex’s 2022 earnings have gone up from $14.21 to $14.61 per share, while that for 2023 has increased from $15.10 to $15.60 per share over the past 30 days.

Vertex has a four-quarter earnings surprise of 3.16%, on average.

Merck’s earnings per share estimates for 2022 have increased from $7.31 per share to $7.38, while that for 2023 has increased from $7.21 per share to $7.34 in the past 30 days. Merck’s stock is up 37.8% in the year-to-date period.

Merck beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 16.07%, on average.

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