Industry News

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 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

Servier Announces New NDC Number for Ivosidenib
Starting today, February 14, 2022, Tibsovo^® (ivosidenib tablets) will use NDC number 72694-0617-6 for ordering. Though the product packing has changed, Servier ensures the product and ordering process remain the same.

For more information, visit the Tibsovo website.

Posted 2/14/2022

New Clinical Trial for Patients with Tumors Harboring NRG1 Fusions
New clinical trial in patients suffering from tumors harboring NRG1 gene alterations, specifically NRG1 gene fusion-positive advanced solid tumors.

To learn more about a prospective real-world outcomes study in patients with tumors harboring NRG1 fusions, click here.

Posted on 12/09/2021.

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

FDA Approves Pembrolizumab for IIB or IIC Melanoma Following Complete Resection

On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda^® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection.

Read the FDA announcement.

Read Merck's announcement.

Posted 12/6/2021

FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

Read the FDA announcement.

Read Merck's announcement.

Posted 11/18/2021

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