Industry News

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.

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Posted 05/17/2022

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

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

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

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

FDA Approves FoundationOne®CDx in Non-Small Cell Lung Cancer
On Thursday, March 17, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne^®CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors that are approved by FDA for this indication.

Read Foundation Medicine's announcement.

Posted 3/17/2022

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

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

FDA Approves FoundationOne®CDx to Identify MSI-H Solid Tumors

Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the FoundationOne^®CDx to be used as a companion diagnostic to identify patients with microsatellite instability high (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s Keytruda^® (pembrolizumab).

Read the Foundation Medicine announcement.

Posted 2/22/2022

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

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