Accelerating the approval process for a potential breakthrough treatment
- AbbVie and Genmab receive FDA priority review for Epkinly in follicular lymphoma
- Application seeks expanded approval for patients with hard-to-treat follicular lymphoma
- Priority review shortens the FDA’s review period
- Target action date set for June 28
- Epkinly would be the first subcutaneous bispecific antibody for this indication
- AbbVie and Genmab are co-developing Epkinly
AbbVie and Genmab have been granted priority review by the FDA for their application to expand the approval of Epkinly in patients with hard-to-treat follicular lymphoma. The application specifically targets adults with relapsed or refractory follicular lymphoma after multiple lines of therapy. The FDA’s priority review designation signifies that Epkinly has the potential to significantly improve the treatment of this serious disease, resulting in a shorter review period. The FDA has set a target action date of June 28 for the application. If approved, Epkinly would be the first and only subcutaneous bispecific antibody available for the treatment of relapsed or refractory follicular lymphoma after two prior lines of therapy. AbbVie and Genmab, in collaboration since 2020, are jointly developing Epkinly. Previously, the FDA and European regulators approved the drug for third-line treatment of relapsed or refractory diffuse large B-cell lymphoma.
Factuality Level: 9
Factuality Justification: The article provides factual information about AbbVie and Genmab winning FDA priority review for their application seeking expanded approval of Epkinly in certain patients with hard-to-treat follicular lymphoma. It includes details about the target action date and the potential impact of the drug if approved. The article does not contain irrelevant information, misleading details, sensationalism, redundancy, or opinion masquerading as fact.
Noise Level: 3
Noise Justification: The article provides relevant information about AbbVie and Genmab winning FDA priority review for their application seeking expanded approval of Epkinly in certain patients with hard-to-treat follicular lymphoma. It includes details about the target action date and the potential impact of the drug. The article stays on topic and supports its claims with specific examples and information.
Financial Relevance: Yes
Financial Markets Impacted: AbbVie and Genmab
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Rating Justification: The article pertains to the pharmaceutical companies AbbVie and Genmab and their application for expanded approval of Epkinly. There is no mention of an extreme event or any significant impact on financial markets.
Public Companies: AbbVie (ABBV)
Private Companies: Genmab
Key People: Colin Kellaher (Author)
Reported publicly:
www.marketwatch.com 
