Oncology Newsfeed

FDA Approves Additional Indication for Pemetrexed in Combination

On December 19, 2022, the U.S. Food and Drug Administration (FDA) approved an additional indication for pemetrexed in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer, with no epidermal growth factor receptor or anaplastic large-cell lymphoma kinase genomic tumor aberrations.

For more information, read Eagle Pharmaceuticals' press release.

Posted 12/21/2022

The Innovation Center Releases EOM Factsheets

Last year, the Center for Medicare & Medicaid Innovation (the Innovation Center) announced the  Enhancing Oncology Model (EOM)—the Oncology Care Model's successor. Now, the Innovation Center has released two resources to help EOM stakeholders understand the model's health equity strategy and new enhanced services requirement. 

• The Health Equity Strategy Factsheet describes key elements of this strategy, including information on health-related social needs in the model and a review of data collection and reporting requirements.
• The Implementing Electronic Patient-Reported Outcomes (ePROs) Factsheet includes more information on the benefits of ePROs and the EOM's gradual implementation requirement of these.

The application period for the EOM closed on October 10, 2022, and the Centers for Medicare & Medicaid Services is in the process of reviewing submitted applications in advance of the model launch on July 1, 2023.

For more information on the EOM, visit its dedicated its dedicated website, email its support team, or call 1.888.734.6433, option 3.

FDA Approves Pafolacianine for Lung Cancer Surgery

On December 16, 2022, the U.S. Food and Drug Administration (FDA) approved the targeted imaging agent pafolacianine for use in lung cancer surgery. This injectable diagnostic binds to cancerous tissue and glows when stimulated by near-infrared light, making it easier for surgeons to remove tumors completely while sparing healthy tissue.

For more information, read the Penn Medicine press release. 

Posted 12/19/2022

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 Accelerated Approval to Adagrasib for KRAS G12C-Mutated NSCLC

On December 12, 2022, the U.S Food and Drug Administration (FDA) granted accelerated approval to adagrasib, a RAS GTPase family inhibitor, for adult patients with KRAS G12C—mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

For more information read the FDA announcement.  

Posted 12/13/2022

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

Roche Receives FDA Approval for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

On November 14, 2022, the U.S Food and Drug Administration (FDA) approved the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry companion diagnostic test to aid in identifying epithelial ovarian cancer patients who are eligible for targeted treatment with mirvetuximab soravtansine-gynx. 

For more information, read the Roche announcement.

Posted 11/16/2022

FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-gynx

On November 14, 2022, the U.S Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx for adult patients with folate receptor alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

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

Posted 11/15/22

FDA Approves Brentuximab Vedotin + Chemo for Pediatric Patients with Hodgkin’s Lymphoma

On November 10, 2022, the U.S Food and Drug Administration (FDA) approved brentuximab vedotin in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma. This is the first pediatric approval for brentuximab vedotin.

For more information, read the FDA announcement.

Posted 11/15/2022