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STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear

STAT

“I do not believe this particular change will have any bearing on patient care,” said Saad Usmani, a myeloma physician and cell therapist at Memorial Sloan Kettering who has also studied Carvykti.

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New data reinforce Keytruda’s dominance in first-line lung cancer

pharmaphorum

Furthermore, the duration of response with the PD-1 checkpoint inhibitor was nearly five times longer at 29 months versus just over six months with frontline chemotherapy. Another contender meanwhile also reported new data at ESMO.

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FDA approves AbbVie-Genmab’s Epkinly to treat DLBCL

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to AbbVie and Genmab ‘s Epkinly (epcoritamab-bysp) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adult patients. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. “As

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Unpleasant truth: the pandemic, record debt and our opportunity for sustainability

pharmaphorum

Beyond significant cost savings, biosimilar uptake has been shown to simultaneously improve patient access, varying by country. A subsequent change in guidance moved this biologic to a first-line treatment, resulting in an increase in the number of patients who could receive this much-needed treatment by 104%.