Julie Beitz named principal drug regulatory expert at Hyman, Phelps &#038; McNamara

FDA grants priority review to Boehringer’s BI 1810631 for the treatment of HER2-mutant advanced NSCLC

FDA granted priority review to Boehringer Ingelheim’s new drug application for BI 1810631 (zongertinib) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have HER2 mutations and who have received prior systemic therapy.

February 21, 2025

Vol.51 No.07

White House

RFK Jr. is confirmed, NCORP stops collecting data on sexual orientation, gender
One month in: Trump’s impact on oncology

Earlier this week, Robert F. Kennedy Jr. was confirmed as secretary of Health and Human Services amid many resignations at federal health agencies and cancellations of NIH and NCAB meetings. All of this happened at a time when the Trump administration is reportedly preparing to fire thousands of HHS workers.

By Claire Marie Porter and Jacquelyn Cobb

FDA approves Adcetris + lenalidomide + rituximab for r/r large B-cell lymphoma

FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.

FDA approves Gomekli for pediatric patients with neurofiromatosis type 1

FDA approved Gomekli (mirdametinib), a kinase inhibitor from SpringWorks Therapeutics, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.

EC grants marketing authorization for Removab as a treatment for malignant ascites

The European Commission granted marketing authorization for Removab (catumaxomab), making the drug the only approved drug therapy for malignant ascites for patients living with this debilitating condition across Europe.