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Incyte
NEWS

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

Shots: The MHLW has approved Incyte’s Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…
December 23, 2025

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Roche
NEWS

Roche Receives the US FDA Approval of Lunsumio VELO for Subcutaneous Use in R/R Follicular Lymphoma

Shots: The US FDA has approved Roche’s Lunsumio VELO (mosunetuzumab) as an SC formulation for the treatment of adults with r/r follicular lymphoma (FL) after ≥2L of systemic therapy, under accelerated approval Approval was based on the P-I/II (GO29781) study in third-line or later FL pts, where Lunsumio VELO demonstrated an ORR of 75% and…
December 23, 2025

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Genmab and AbbVie
NEWS

Genmab and AbbVie Report the US FDA Approval of Epkinly to Treat R/R Follicular Lymphoma

Shots: The US FDA has approved Epkinly (epcoritamab-bysp) + rituximab & lenalidomide (R2) for the treatment of adults with r/r follicular lymphoma (FL) & converted accelerated approval of Epkinly monotx. to full approval for r/r FL following ≥2L of systemic therapy Approval was based on P-III (EPCORE FL-1) trial assessing Epkinly + R2 (n=243)vs R2 alone(n=245)in…
November 19, 2025

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VIEWPOINTS

Regeneron at ASH’24: Aafia Chaudhry in a Stimulating Dialogue Exchange with PharmaShots 

Shots:   Recently, Regeneron presented Odronextamab’s data in treating patients with different B-NHL subtypes (OLYMPIA studies) and marginal zone lymphoma (ELM-2 study)  Aafia Chaudhry, Vice President, Global Program Head for Hematology-Oncology at Regeneron, discusses Odronextamab’s ongoing studies as monotherapy and in combination to treat various malignancies  Aafia shares the upcoming PDUFA date on July 30th for…
July 2, 2025

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Viewpoints_Jacqueline Nielsen_Tahi Ahmadi
VIEWPOINTS

Unlocking Approval: Jacqueline Nielsen from AbbVie & Tahi Ahmadi from Genmab in a Riveting Conversation with PharmaShots

Shots:  Recently, the EMA’s CHMP adopted a positive opinion by recommending conditional marketing authorization for AbbVie and Genmab’s Tepkinly for the treatment of R/R Follicular Lymphoma  Today at PharmaShots, we have Jacqueline Nielsen, Head of Hematologic Oncology Affairs at AbbVie, and Tahi Ahmadi, EVP and CMO at Genmab, shedding light on this conditional marketing authorization…
September 18, 2024

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