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
May 31, 2022
On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved both nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of programmed death-ligand 1 (PD-L1) status.
For more information, read Bristol Myers Squibb's announcement .
Posted 5/31/2022
May 31, 2022
On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel 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 Novartis' announcement .
Posted 5/31/2022
May 26, 2022
On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test, in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.
Read the FDA announcement .
Read Servier's announcement .
Posted 5/26/2022
May 12, 2022
On May 10, 2022, it was announced that the Eisai lenvatinib dose exchange program has been expanded to cover all indicated dose reductions for patients with endometrial cancer who require a new prescription. The program will allow dose exchanges for up to 15 days of a patient's current dose for one that is lower, once per quarter, and at no cost.
For more information, read the news article .
Posted 5/12/2022
May 5, 2022
On May 4, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and who have developed disease recurrence during or within six months of completing therapy.
Read the FDA announcement .
Read AstraZeneca and Daiichi Sankyo's announcement .
Posted 5/5/2022
May 2, 2022
The American Society of Clinical Oncology (ASCO) has updated its 2022 guideline for biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer to include the Oncotype DX Breast Recurrence Score ® test. This test is recommended for use in postmenopausal patients with up to three positive axillary lymph nodes, irrespective of clinical risk.
For more information, read Exact Sciences' announcement and the ASCO guideline update .
Posted 5/2/2022
April 18, 2022
On Monday, April 18, 2022, the U.S. Food and Drug Administration (FDA) approved Alymsys ® (bevacizumab-maly), a biosimilar to Avastin ® (bevacizumab). Alymsys' approved indications include:
Read Brand Institute's announcement for more information.
Posted 4/18/2022
April 14, 2022
Effective April 16, 2022, Secretary of Health and Human Services (HHS) Xavier Becerra renewed the COVID-19 public health emergency that has existed nationwide since January 27, 2020.
For more information, visit the HSS website .
Posted 4/14/2022
April 4, 2022
On Friday, April 1, 2022, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.
Read the FDA announcement .
Read Gilead's announcement .
Posted 4/4/2022