FDA Expands AbbVie's (ABBV) Epkinly Label in Follicular Lymphoma [Yahoo! Finance]
Genmab A/S - American Depositary Shares (GMAB)
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Source: Yahoo! Finance
The FDA approved Epkinlyunder the accelerated pathway to treat adults with relapsed or refractory (R/R) FL after two or more lines of therapies. The agency initially granted accelerated approval to the drug last year to treat patients with R/R diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma who have received at least two lines of therapies. Post the label expansion, the AbbVie/Genmab drug is the first T-cell-engaging bispecific antibody approved in the U.S. to treat adult patients with R/R FL and R/R DLBCL who have already received two or more treatments. 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 FDA approval is 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 (ORR) of 82%, including a complete respo
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News
- 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
- Genmab A/S (NASDAQ: GMAB) had its price target raised by analysts at BTIG Research from $46.00 to $47.00. They now have a "buy" rating on the stock.MarketBeat