FDA Approves Lisocabtagene Maraleucel for Second-Line Large B-cell Lymphoma
June 27th 2022Lisocabtagene maraleucel (liso-cel, Breyanzi; Bristol Myers Squibb) approved for the second-line treatment of patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B.
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FDA Approves Expanded Indication for Vaxneuvance Pneumococcal Vaccine
June 22nd 2022Vaxneuvance is now indicated for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.
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FDA Advisory Committee Recommends EUA for Novavax COVID-19 Vaccine
June 8th 2022The FDA Vaccines and Related Biological Products Advisory Committee voted nearly unanimously for an emergency use authorization for the Novavax COVID-19 vaccine, NVX-CoV2373, for use in individuals 18 years of age and older.
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FDA Approves New Indication for Rituximab Biosimilar for Rheumatoid Arthritis
June 7th 2022In addition to the new approval for rheumatoid arthritis, Riabni has already been approved for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
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Enhertu Lowers Risk of Disease Progression, Death by 50% in HER2-Low Metastatic Breast Cancer
June 5th 2022Trastuzumab deruxtecan shows superior and clinically meaningful progression-free survival and overall survival benefit in patients with HER2-low unresectable and/or metastatic breast cancer with hormone receptor-positive or negative disease.
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Brentuximab Vedotin Combo Lowers Risk of Death in Patients With Hodgkin Lymphoma
June 4th 2022Brentuximab vedotin (Adcetris) plus doxorubicin, vinblastine, and dacarbazine shows improved overall survival compared with standard chemotherapy in patients with previously untreated, advanced stage classical Hodgkin lymphoma.
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FDA Grants Breakthrough Therapy Designation to Repotrectinib for ROS1-Positive Metastatic NSCLC
May 12th 2022Repotrectinib awarded breakthrough therapy designation for patients with ROS1-positive metastatic non–small cell lung cancer previously treated with a ROS1 tyrosine kinase inhibitor and who were not previously administered platinum-based chemotherapy.
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