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
August 25, 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
August 15, 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
August 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
August 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
August 12, 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
August 11, 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
August 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.
August 8, 2022
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
August 5, 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
July 19, 2022
On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib for adult and pediatric patients at least a year old, with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors.
For more information, read the FDA announcement .
Posted 7/19/2022
July 18, 2022
On July 15, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Medicare Hospital Outpatient Prospective Payment System (HOPPS) proposed rule, including proposals that align with several key goals of the Biden Administration like advancing health equity in rural areas, promoting competition in the healthcare system, and promoting safe, effective, patient-centered care.
For more information, read the proposed rule and the CMSfact sheet .
Posted 7/18/2022
July 14, 2022
Administrator of the Centers for Medicare & Medicaid Services (CMS) Chiquita Brooks-LaSure and her leadership team will provide an update on the agency's recent accomplishments, including how its initiatives are advancing the CMS strategic plan. When : July 19, 2022 from 1:00-2:00 PM EDT. Who : National and local CMS stakeholders and partners. Register to attend and visit the CMS website for more information.
Posted 7/14/2022
July 8, 2022
On July 7, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Physician Fee Schedule (PFS) proposed rule, which would significantly expand access to behavioral health services, Accountable Care Organizations (ACOs), cancer screening, and dental care—particularly in rural and underserved areas.
“Integrated coordinated, whole-person care—which addresses physical health, behavioral health, and social determinants of health—is crucial for people with Medicare, especially those with complex needs,” said Dr. Meena Seshamani, deputy administrator at CMS and director of the Center for Medicare. “If finalized, the proposals in this rule will advance equity, lead to better care, support healthier populations, and drive smarter spending of the Medicare dollar.
For more information, read the proposed rule as well as the CMS press release and fact sheet .
Posted 7/8/2022
June 29, 2022
On June 27, 2022, the Biden Administration, through the Department of Health and Human Services and Centers for Medicare & Medicaid Services (CMS), announced a new model to improve cancer care for Medicare patients: the Enhancing Oncology Model (EOM). This model is the successor to the Oncology Care Model (OCM).
The EOM—designed by the Center for Medicare and Medicaid Innovation—will tackle the health inequities and meet patients' throughout the cancer care continuum, with an emphasis on person-centered care and better patient outcomes. The model will run from July 2023 through June 2028, and its participants will include oncology practices that treat people with Medicare undergoing chemotherapy for breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer.
For additional information regarding the EOM, visit the CMS website . Then read ACCC's statement .
Posted 6/29/2022
June 29, 2022
On June 22, 2022, the U.S Food and Drug Administration (FDA) approved dabrafenib and trametinib for the treatment of adult and pediatric patients 6 years of age and older, with unresectable or metastatic solid tumors with BRAF V600E mutation, who have progressed following prior treatment and have no satisfactory alternative treatment options.
For more information, read the FDA announcement and the Novartis announcement .
June 28, 2022
On June 24, 2022, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
For more information, read the FDA announcement and Bristol Myers Squibb's announcement .
Posted 6/28/2022
June 9, 2022
On June 9, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne ® CDx as a companion diagnostic for two entrectinib indications:
Both indications are for patients who may be appropriate for treatment with entrectinib.
For more information, read Foundation Medicine's announcement and Roche's announcement .
Posted 6/9/2022
May 31, 2022
On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved Amneal's biologics license application for Fylnetra™ (pegfilgrastim-pbbk), a biosimilar referencing Neulasta ® (Agmen).
For more information, read Amneal's announcement .
Posted 5/31/2022