Oncology Newsfeed

FDA Approves Selpercatinib for Lung & Thyroid Cancers with RET Mutations or Fusions

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:

• Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC);
• Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;
• Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
  

FDA Approves Capmatinib for Adults with Metastatic NSCLC

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

NAM to Host Webinar on Supporting Clinician Well-Being During COVID-19

• Describing the existing clinician burnout crisis prior to the COVID-19 pandemic and the goals of the Action Collaborative on Clinician Well-Being and Resilience.
• Identifying the critical needs and priorities to support the well-being of clinicians, including those in training, during the COVID-19 era.
• Spotlighting programs, resources, and leadership efforts currently underway to address and monitor the acute and long-term mental health and well-being of clinicians on the frontlines of COVID-19.
• Voicing the need for a coordinated, national strategy to care for the acute and long-term health and well-being of frontline clinicians delivering healthcare during this public health crisis.
  

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

FDA Issues Emergency Use Authorization for Remdesivir for Severe COVID-19

CMS Issues Sweeping Regulatory Waivers & Changes to Further Expand Telehealth Options

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:

• Expanding the types of providers able to provide services via telehealth to Medicare beneficiaries to include physical therapists, occupational therapists, and speech language pathologists.
• Allowing hospitals to bill for telehealth services provided by hospital-based practitioners in Medicare outpatient settings (including when patients are at home when the home is serving as a temporary provider-based department of the hospital). The agency states that this might include counseling, educational, and therapy services.
• Expanding the types of services reimbursable under Medicare for audio-only telehealth visits to include behavioral health and patient education services, and increasing reimbursement (retroactively to March 1) for audio-only telehealth visits. 
  
• Waiving the video requirement for telehealth E/M services. These are now added to the list of audio-only telehealth services that are reimbursable visits.
• Expediting the process for adding new services to the list of those Medicare services that can be provided by telehealth.
• Permitting rural health clinics and federally qualified health clinics to provide telehealth as a distant site, thus enabling Medicare beneficiaries to receive care from home.

FDA Approves Daratumumab and Hyaluronidase-fihj for Multiple Myeloma

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:

• in combination with bortezomib, melphalan and prednisone  in newly diagnosed patients who are ineligible for autologous stem cell transplant,
• in combination with lenalidomide and dexamethasone  in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy,
• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy,
• as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

FDA Approves Niraparib for Frontine Maintenance of Advanced Ovarian Cancer

CMS Re-evaluating Accelerated Payment Program; Halting Advance Payment Program

President Trump Signs $484 Billion Coronavirus Relief Package

House Passes Coronavirus Rescue Funding Package Totaling Nearly $500 Billion

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