FDA Updates Capecitabine Indications and Dosing Regimens

On December 14, 2022, the U.S Food and Drug Administration (FDA) approved updated labeling for capecitabine under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for older, commonly prescribed oncology drugs.

Capecitabine is now approved for the following new and revised indications:

• Adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen
• Perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy
• Treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen
• Treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated
• Treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy
• Treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen
• Treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen
• Adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

Additional labeling revisions include:

• The dosage regimen is revised and updated for several indications, including the option for a lower starting dose for patients with metastatic breast cancer
• Severe renal impairment is removed as a contraindication
• Information on risks from exposure to crushed tablets is added under warnings and precautions
• Additional information is provided on the use of capecitabine and dihydropyrimidine dehydrogenase (DPD) deficiency
• Clinical pharmacology information is updated and revised
• The patient counseling information section and patient information document are updated and revised.

For more information, read the FDA announcement.

Posted 12/16/2022

FDA Grants Approval to Atezolizumab for Alveolar Soft Part Sarcoma

On December 9, 2022, the U.S Food and Drug Administration (FDA) approved atezolizumab for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma.

For more information read the FDA announcement.

Posted 12/12/2022

FDA Approves a New Dosing Regimen for Asparaginase Erwinia Chrysanthemi

On November 18, 2022, the U.S Food and Drug Administration (FDA) approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn. Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. 

For more information, read the FDA announcement.

Posted 11/21/2022

FDA Approves Tremelimumab with Durvalumab + Chemotherapy for Metastatic NSCLC

On November 10, 2022, the U.S Food and Drug Administration (FDA) approved tremelimumab in combination with durvalumab and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase genomic tumor aberrations.

For more information, read the FDA announcement.

Posted 11/15/2022

FDA Approves Cemiplimab + Chemotherapy for NSCLC

On November 8, 2022, the U.S Food and Drug Administration (FDA) approved cemiplimab-rwlc in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.

For more information, read the FDA Announcement and the Regeneron press release.

Posted 11/9/2022

FDA Approves Tremelimumab in Combination with Durvalumab for Unresectable HCC

On October 21, 2022, the U.S Food and Drug Administration (FDA) approved tremelimumab in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (HCC). 

For more information, read the FDA announcement and the AstraZeneca announcement. 

Posted 10/24/2022

FDA Grants Accelerated Approval to Futibatinib for Cholangiocarcinoma

On September 30, 2022, the Food and Drug Administration (FDA) granted accelerated approval to futibatinib for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.

For more information read the FDA announcement.

Posted 10/3/2022

FDA Expands Selpercatinib Approval for RET Fusion-Positive Solid Tumors

On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

For more information, read the FDA announcement and the Lilly announcement. 

Posted 9/22/2022

FDA Approves Durvalumab + Gemcitabine for Biliary Tract Cancer

 On September 2, 2022, the U.S Food and Drug Administration (FDA) durvalumab in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. 

For more information, read the FDA announcement, and the AstraZeneca announcement. 

Posted 9/8/2022

GSK Shares Plans to Voluntarily Withdraw Niraparib

GlaxoSmithKline (GSK) is planning to voluntarily withdraw the indication of niraparib for treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status.

For more information read the GSK letter.

Posted 9/7/2022