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
May 11, 2020
On May 8, 2020, the U.S. Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for the following indications:
Read the full FDA announcement here .
Posted 5/11/2020
May 6, 2020
On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
On the same day, the FDA also approved the FoundationOne CDx assay (Foundation Medicine, Inc.) as a companion diagnostic for capmatinib. Read FDA announcement .
Posted 5/6/2020
May 4, 2020
The National Academy of Medicine (NAM) will host a webinar on Supporting Clinician Well-Being During COVID-19 on Thursday, May 7 from 1:00 to 3:30 PM ET. Webinar objectives include:
Questions for the panelists can be submitted as you register for the event and during the webinar.A recording of this webinar, slides, and transcript will be available after the event. More information and registration here .
Posted 5/4/2020
May 1, 2020
On May 1, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.
The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. Read the full FDA announcement .
Posted 5/1/2020
May 1, 2020
On April 30, the Centers for Medicare & Medicaid Services (CMS) issued another round of sweeping regulatory waivers and rule changes aimed at further increasing access to telehealth for Medicare beneficiaries in response to the COVID-19 public health emergency. Among the announced changes, CMS is:
Read the CMS announcement for full details.
Posted 5/1/2020
May 1, 2020
On May 1, 2020, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.
Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received:
Read FDA announcement .
Posted 5/1/2020
April 29, 2020
On April 29, 2020, the U.S. Food and Drug Administration approved niraparib (Zejula, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. Read the FDA announcement .
Posted 4/29/2020
April 27, 2020
On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately.
CMS states that significant additional funding will continue to be available to hospitals and other healthcare providers through other programs such as the Coronavirus Aid, Relief, and Economic Security (CARES) Act (PL 116-136) and the Paycheck Protection Program and Health Care Enhancement Act (PL 116-139) for healthcare providers. The U.S. Department of Health and Human Services (HHS) is distributing these funds through the Provider Relief Fund , and these payments do not need to be repaid.
View CMS' updated fact sheet on the Accelerated Payment Program and Advance Payment Program here .
Posted 4/27/2020
April 24, 2020
On Friday, April 24, President Trump signed into law a $484 billion coronavirus relief package. Congress passed the legislation earlier this week. Included in the emergency funding is $75 billion for hospitals and $25 billion for coronavirus testing. Read a summary of the Paycheck Protection and Health Care Enhancement Act (courtesy of the American Medical Association).
Posted 4/24/2020