ONCOLOGY NEWSFEED

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

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

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

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

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

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

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

On August 24, 2022, the U.S Food and Drug Administration (FDA) approved ibrutinib for the treatment of pediatric patients one year and older with chronic graft-versus-host disease after failure of one or more lines of systemic therapy.

For more information, read the FDA announcement .

Posted 8/25/2022

On August 12, 2022, the U.S. Food and Drug Administration (FDA) approved Guardant360 ^® CDx liquid biopsy test as a companion diagnostic (CDx) to select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC), whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, for treatment with AstraZeneca and Daiichi Sankyo's Enhertu ^® (fam-trastuzumab deruxtecan-nxki).

For more information, read Guardant Health's announcemen t.

Posted 8/15/2022

On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

For more information, read the FDA announcement or the AstraZeneca and Daiichi Sankyo announcement .

Posted 8/15/2022

On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

For more information, read the FDA announcement .

Posted 8/15/2022

On August 5, 2022, the U.S. Food and Drug Administration approved the new tablet formulation for acalabrutinib for all current indications, including chronic lymphocytic leukaemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.

For more information, read AstraZeneca's announcement .

Posted 8/12/2022

On August 11, 2022, AstraZeneca released a letter stating that that there is a "potential detrimental effect on the overall survival" for olaparib. Therefore, the company has announced it is planning to voluntarily withdraw the olaparib indication for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

For more information, read the letter sent by AstraZeneca.

Posted 8/11/2022

On August 11, 2022, the U.S Food and Drug Administration (FDA) approved a label expansion for the VENTANA MMR RxDx Panel, a companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA mismatch repair, and who may be eligible for treatment with Keytruda ^® (pembrolizumab).

For more information read the Roche announcement.

On August 5, 2022, the U.S Food and Drug Administration (FDA) approved a supplemental new drug application for darolutamide in combination with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

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

Posted 8/8/2022

On August 5, 2022, the U.S Food and Drug Administration (FDA) approved fam-trastuzumab-deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-low breast cancer.

For more information, read the FDA announcement .

Posted 8/5/2022