AbbVie (ABBV) Gets CHMP Nod for Lymphoma Drug's Expanded Use [Yahoo! Finance]
Genmab A/S - American Depositary Shares (GMAB)
Company Research
Source: Yahoo! Finance
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 I
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- AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma [Yahoo! Finance]Yahoo! Finance
- Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Treatment of Adults with Relapsed/ Refractory Follicular Lymphoma [Yahoo! Finance]Yahoo! Finance
- Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Treatment of Adults with Relapsed/ Refractory Follicular LymphomaBusiness Wire
- Epcoritamab (TEPKINLY®) Receives Positive CHMP Opinion for the Treatment of Adults with Relapsed/ Refractory Follicular LymphomaGlobeNewswire
- FDA Expands AbbVie's (ABBV) Epkinly Label in Follicular Lymphoma [Yahoo! Finance]Yahoo! Finance