June 30, 2020
On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Read FDA announcement .
Posted 6/30/2020
June 29, 2020
On June 29, 2020, the U.S. Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (Phesgo, Genentech, Inc.) for subcutaneous injection for the following indications:
Read the FDA announcement .
Posted 6/29/2020
June 23, 2020
On June 23, the Centers for Medicare & Medicaid Services (CMS) released a preliminary snapshot of the COVID-19 pandemic's impact on the Medicare population, based on Medicare claims data.
The data released today includes the total number of reported COVID-19 cases and hospitalizations among Medicare beneficiaries between January 1 and May 16, 2020. The snapshot breaks down COVID-19 cases and hospitalizations for Medicare beneficiaries by state, race/ethnicity, age, gender, dual eligibility for Medicare and Medicaid, and urban/rural locations.
CMS data shows that more than 325,000 Medicare beneficiaries received a diagnosis of COVID-19 between January 1 and May 16, 2020. During this same time period, nearly 110,000 Medicare beneficiaries were hospitalized for COVID-19-related treatment. According to the CMS snapshot released today, Black Medicare beneficiaries were hospitalized with COVID-19 at a rate nearly four times higher than whites.
CMS data shows that:
Access CMS' Preliminary Medicare COVID-19 Data Snapshot and additional information here .
Posted 6/23/2020
June 23, 2020
On June 23, the Centers for Medicare & Medicaid Services (CMS) announced creation of the Office of Burden Reduction and Health Informatics. The new office is intended to consolidate CMS' efforts to reduce regulatory and administrative burden, according to the agency's announcement. The unveiling of the new office, "permanently embeds a culture of burden reduction" across all platforms of CMS operations, the agency said. Read the CMS announcement .
Posted 6/23/2020
June 22, 2020
On June 22, 2020, Karyopharm Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has approved oral Xpovio ® (selinexor), the company’s first-in-class, selective inhibitor of nuclear export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved based on response rate under the FDA’s Accelerated Approval Program. Read the corporate press release .
Posted 6/22/2020
June 18, 2020
On June 18, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options.
On the same day, the FDA also approved the cobas EZH2 Mutation Test (Roche Molecular Systems, Inc.) as a companion diagnostic for tazemetostat. Read FDA announcement .
Posted 6/18/2020
June 17, 2020
On June 17, the Centers for Medicare & Medicaid Services (CMS) released the " Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (CMS 2482-P) ."
The agency states that the proposals put forward support state flexibility to enter innovative value-based purchasing arrangements (VBPs) with drug manufacturers for new expensive therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. The proposed rule also creates minimum standards in state Medicaid Drug Utilization Review (DUR) programs designed to reduce opioid-related fraud, misuse and abuse. Read the CMS fact sheet on the proposed rule . Access the proposed rule .
Read HealthAffairsblog by CMS Administrator Seema Verma .
Posted 6/17/2020
June 17, 2020
On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab. Read the FDA announcement .
Posted 6/17/2020
June 16, 2020
On June 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Read the FDA announcement .
Posted 6/16/2020
June 15, 2020
On June 12, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.
Read the corporate press release .
Posted 6/15/2020
June 12, 2020
On June 11, 2020, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Nyvepria ™ (pegfilgrastim-apgf), a biosimilar to Neulasta ® (pegilgrastim). Nyvepria is indicated to decrease incidence of infection as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Read corporate press release .
Posted 6/12/2020
June 11, 2020
On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. Read the FDA announcement .
Posted 6/11/2020
June 10, 2020
June 10, 2020, the American Society for Radiation Oncology (ASTRO) released a new clinical guideline that provides recommendations for radiation therapy to treat patients with nonmetastatic cervical cancer. The guideline, ASTRO's first for cervical cancer, was published online in Practical Radiation Oncology .
Included within the recommendations are indications and best practices for external beam radiation therapy and brachytherapy in the postoperative and definitive settings. Recommendations also address other treatments including chemotherapy and surgery when used in combination with radiation. Read ASTRO press release . Access the clinical guideline .
Posted 6/10/2020
June 3, 2020
On Wednesday, June 3, the Center for Medicare & Medicaid Innovation (CMMI) announced that, in response to the COVID-19 public health emergency (PHE), CMMI is providing new flexibilities and adjustments to current and future Innovation Center models. The announcement included the following changes specifically for Oncology Care Model (OCM).
Payment Methodology:
Quality Reporting:- Make the following optional for the affected performance periods:
-Remove the requirement for cost and resource utilization reporting and practice transformation plan reporting in July/August 2020.
Timeline: Extend model for 1 year through June 2022.
The CMS Innovation Center will host a call on Friday, June 5, 2020, from 2:00 PM – 3:00 PM ET to provide an overview of the Oncology Care Model adjustments and flexibilities and answer your questions.
When: Friday, 06/05/2020 from 2:00 PM – 3:00 PM ETRegister Here . View information on the CMMI website here . Read a Health Affairs blog post by CMS Administrator Seema Verma.
Posted 6/3/2020
June 2, 2020
On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab in combination with bevacizumab (Tecentriq and Avastin, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Read full FDA announcement .
Tecentriq prescribing information and billing/coding for HCC .
Avastin prescribing information and billing/coding for HCC .
Posted 6/2/2020
June 2, 2020
On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Read full FDA announcement .
Posted 6/2/2020
May 27, 2020
On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol Myers Squibb Co.) plus ipilimumab (Yervoy, Bristol Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Read full FDA announcement.
Posted May 27, 2020
May 26, 2020
On May 22, 2020, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
On the same day, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic for brigatinib. Read full FDA announcement .
Posted 5/26/2020
May 20, 2020
On May 19, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.
On the same day, the FDA also approved FoundationOne CDx (Foundation Medicine, Inc.) for selection of patients with mCRPC carrying HRR gene alterations and BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) for selection of patients with mCRPC carrying germline BRCA1/2 alterations as companion diagnostic devices for treatment with olaparib. Read full FDA announcement .
Posted 5/20/2020
May 15, 2020
On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock) for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with GIST who were previously treated with imatinib, sunitinib, and regorafenib. Read the full FDA announcement .
Posted 5/15/2020
May 15, 2020
On May 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial in 115 patients with BRCA -mutated (germline and/or somatic) mCRPC who had been treated with androgen receptor-directed therapy and taxane-based chemotherapy. Read full FDA announcement .
Posted 5/15/2020
May 15, 2020
On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
The FDA also approved the PD-L1 IHC 28-8 pharmDx (Agilent Technologies, Inc.) as a companion diagnostic device for selecting patients with NSCLC for treatment with nivolumab plus ipilimumab. Read full FDA announcement .
Posted 5/15/2020
May 15, 2020
On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy (HAART) and Kaposi sarcoma in adult patients who are HIV-negative.
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Read the FDA announcement .
Posted 5/15/2020
May 11, 2020
On May 8, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic test. Read FDA announcement . Read the corporate press release.
Posted 5/11/2020