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FDA Approves Tisagenlecleucel for R/R Follicular Lymphoma
On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.
For more information, read Novartis' announcement.
Posted 5/31/2022
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Fam-Trastuzumab Deruxtecan-Nxki Approved for Patients with HER2+ MBC
Fam-Trastuzumab Deruxtecan-Nxki (Enhertu®, Daiichi Sankyo, AstraZeneca) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Read press release.
Posted 05/17/2022
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FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma
On Friday, April 1, 2022, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.
Read the FDA announcement.
Read Gilead's announcement.
Posted 4/4/2022
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FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Prostate Cancer
On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
Read the FDA announcement.
Read Novartis' announcement.
Posted 3/24/2022
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FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma
On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
Read the FDA announcement.
Read Merck's announcement.
Posted 3/22/2022
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FDA approves nivolumab and relatlimab-rmbw for melanoma
On March 18, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Read the FDA announcement.
Read Bristol Myers Squibb's announcement.
Posted 3/21/2022
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FDA Approves Olaparib for High-Risk Early Breast Cancer
On Friday, March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
Read the FDA announcement.
Read AstraZeneca's announcement.
Posted 3/14/2022
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FDA Approves Nivolumab in Combination for Early-Stage NSCLC
On Friday, March 4, 2022, the U.S. Food and Drug Administration approved nivolumab with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting.
Read the FDA announcement.
Read Bristol Myers Squibb's announcement.
Posted 3/7/2022
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FDA Approves Ciltacabtagene Autoleucel for R/R Multiple Myeloma
On Monday, February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel for the treatment of adults with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Read Janssen's announcement.
Posted 3/1/2022
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FDA Approves Rituximab + Chemotherapy for Pediatric Cancer Indications
On December 2, 2021, the U.S. Food and Drug Administration approved rituximab in combination with chemotherapy for pediatric patients (greater than or equal to 6 months to less than 18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.
Read the FDA announcement.
Posted 12/6/2021