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
April 23, 2020
On Thursday, April 23, the U.S. House of Representatives passed the coronavirus rescue package totaling nearly $500 billion by a vote of 388-5-1. Four conservative Republicans broke with the GOP leadership to vote against the bill, referencing the impact on the federal deficit. The Senate passed the legislation unanimously by voice vote earlier this week.
The legislation would bring an immediate $321 billion in funding for the Paycheck Protection Program, the small business rescue fund that was depleted last week. The rescue package would also provide $75 billion in emergency relief for hospitals, $25 billion to ramp up coronavirus testing, and an additional $60 billion in economic disaster loans for small businesses.
The bill now goes to President Trump, who is expected the sign the legislation into law.
Posted 4/23/2020
April 22, 2020
On April 22, the Centers for Medicare & Medicaid Services (CMS) released a new toolkit to help state and local healthcare decision-makers in managing healthcare workforce challenges in response to the COVID-19 emergency. The online toolkit, developed by the Healthcare Resilience Task Force, includes a full suite of available resources to aid in response based on state and local needs. Access the COVID-19 Workforce Virtual Tookit .
Posted 4/22/2020
April 22, 2020
On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy™) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. Read FDA announcement . Read corporate press release .
Posted 4/22/2020
April 22, 2020
The Office of the National Coordinator for Health Information Technology (ONC) announced April 21 that due to the COVID-19 public health emergency, ONC will exercise its discretion in enforcing all new requirements that have compliance dates and time frames until three months after each initial compliance date or timeline identified in the ONC Cures Act Final Rule. Learn more.Cures Final Act Rule Enforcement Discretion Dates & Timeframes . CMS press release . CMS announcement .
Posted 4/22/2020
April 21, 2020
On Tuesday, April 21, the U.S. Senate passed by voice vote a $484 billion coronavirus relief bill that includes $75 billion for providers. It is anticipated that House members will vote on the legislation on Thursday.
Source: InsideHealthPolicy Posted 4/21/2020
April 21, 2020
On April 21, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
This review was conducted under Project Orbis , an initiative of the FDA Oncology Center of Excellence. Read the FDA announcement .
Posted 4/21/2020
April 20, 2020
On April 19, the Centers for Medicare & Medicaid Services (CMS) released guidance for facilities in areas with a low, or relatively low and stable incidence of COVID-19, to resume providing non-emergent, non-COVID-19 healthcare services. Many non-essential surgeries and procedures have been curtailed since March 18 when the agency recommended that facilities limit non-essential care to preserve personal protective equipment (PPE) and prepare for potential surge areas.
The CMS guidance references the White House plan for Opening Up America, released on Friday, April 17. The agency's guidance titled, Opening Up America Again, Centers for Medicare & Medicaid Services (CMS) Recommendations Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I , notes that "if states or regions have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I." Access the CMS guidance .
Posted 4/20/2020
April 20, 2020
On April 17, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
The FDA also approved the FoundationOne ® CDX (Foundation Medicine, Inc.) as a companion diagnostic for patient selection. Read FDA announcement .
Posted 4/20/2020
April 17, 2020
On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments. Read FDA announcement.
Posted 4/17/2020