ONCOLOGY NEWSFEED

On January 26, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

For more information read the FDA announcement and the Merck announcement .

Posted 1/27/2023

On January 19, 2023, the U.S Food and Drug Administration (FDA) approved zanubrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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

Posted 1/20/2023

On January 19, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to tucatinib in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

For more information read the FDA announcement .

Posted 1/20/2023

Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the use of FoundationOne®Liquid CDx as a companion diagnostic to identify patients with ROS1 -positive non-small cell lung cancer or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with entrectinib.

For more information, read the Foundation Medicine announcement .

Posted 1/5/2023

On December 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb 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 Genetech's new release .

Posted 12/23/2022

On December 21, Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) approved its FoundationOne ^® Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors approved by the FDA for this indication.

For more information, read Foundation Medicine's press release .

Posted 12/21/2022

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

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.

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

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

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

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

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

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

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

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

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

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

The Centers for Medicare & Medicaid Services (CMS) has finalized changes in CMS’s annual Physician Fee Schedule (PFS) proposed rule to significantly expand access to behavioral health services and moves the health system closer to achieving equitable outcomes through high quality, affordable, person-centered care. These changes will ensure CMS continues to deliver on their goals of advancing health equity, driving accountable care, and protecting the sustainability of the Medicare program.

For more information, read the press release .

Posted 11/2/2022.

On October 25, 2022, the U.S. Food and Drug Administration (FDA) granted an accelerated approval to teclistamab-cqyv for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior treatments.

For more information, read the FDA announcement .

Posted 10/27/2022

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

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

On September 28, 2022, the U.S. Food and Drug Administration (FDA) approved Vegzelma ^® (bevacizumab-adcd), a biosimilar to Avastin® (bevacizumab), for the treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, and metastatic cervical and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

For more information read the Business Wire press release .

Posted 9/28/2022

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