ONCOLOGY NEWSFEED

On March 22, 2023, the U.S Food and Drug Administration granted accelerated approval to retifanlimab-dlwr for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

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

Posted 3/22/2023

On March 16, 2023, the U.S Food and Drug Administration (FDA) approved dabrafenib with trametinib for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

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

Posted 3/20/2023

On March 6, 2023 the U.S Food and Drug Administration (FDA) approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv, a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

For more information read the Coherus Biosciences announcement .

Posted 3/8/2023

On March 3, 2023, the U.S Food and Drug Administration (FDA) approved an expanded indication for abemaciclib, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence.

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

Posted 3/6/2023

On January 27, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.

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

Posted 3/3/2023

On February 9, 2023, the U.S Food and Drug Administration (FDA) approved dostarlimab-gxly for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

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

Posted 2/10/2023

On February 3, 2023, the U.S Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

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

Posted 2/6/2023

On January 30, 2023, the Biden Administration informed Congress it will end the COVID-19 national and public health emergencies May 11— signaling an end to the pandemic's crisis era and an unwinding of federal flexibilities that reshaped the nation's healthcare system.

For more information, read the statement from the Executive Office of the President.

Posted 2/1/2023

On January 27, 2023, the U.S Food and Drug Administration (FDA) approved elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

For more information, read the FDA announcement .

Posted 1/30/2023

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