December 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
December 19, 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 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.
December 19, 2022
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
December 16, 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:
Additional labeling revisions include:
For more information, read the FDA announcement .
Posted 12/16/2022
December 13, 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
December 12, 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
November 21, 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
November 16, 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
November 15, 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
November 15, 2022
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
November 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
November 9, 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
November 2, 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.
October 27, 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
October 24, 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
October 3, 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
September 28, 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
September 22, 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
September 13, 2022
The Patient and Professional Partnerships team at Foundation Medicine has announced a call for grants subject to certain terms. The deadline to submit full grant proposal is November 29th, 2022, and the grant will be awarded on December 14th, 2022.
Foundation Medicine, Inc. provides support to nonprofit groups that prioritize patient advocacy, patient services, and patient education. This award is intended to help projects that address oncology care inequities and are centered on the cancer community. Support requests must be connected to healthcare and appropriate for Foundation Medicine, Inc.'s active therapeutic or technological cancer areas. Only applications which include a collaboration between two separate organizations will be considered, and applicants must be based in the U.S.
For more information and to receive instructions about the application process, email Foundation Medicine .
Posted 9/13/2022
September 12, 2022
On September 9, 2022, the U.S. Food and Drug Administration (FDA) approved eflapegrastim-xnst to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with nonmyeloid malignancies who are receiving myelosuppressive treatment.
For more information, read the Spectrum Pharmaceuticals announcement .
Posted 9/12/2022
September 8, 2022
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
September 7, 2022
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
August 30, 2022
On August 26, 2022, the U.S Food and Drug Administration (FDA) approved pemigatinib for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
For more information, read the FDA announcement .
Posted 8/30/2022
August 30, 2022
On August 29, 2022, the Centers for Medicare & Medicaid Services (CMS) published a final rule ( CMS-5527-F2 ) that finalized delaying the Radiation Oncology Model start date until a date is determined through future rulemaking.
For more information, visit the Radiation Oncology Model website .
Posted 8/30/2022