FDA Approves Capmatinib Tablets for Metastatic NSCLC

On May 6, 2020, the U.S. Food and Drug Administration (FDA) approved capmatinib (Tabrecta™, Novartis Pharmaceuticals Corporation) tablets for the treatment of 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.

This indication is approved under accelerated approval based on overall response rate and duration of response.

Read the corporate press release.

Posted 5/12/2020

FDA Approves Olaparib + Bevacizumab as Maintenance Treatment for Advanced Ovarian Cancer

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

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

FDA Approves Niraparib for Frontine Maintenance of Advanced Ovarian Cancer

FDA Approves Tukysa™ for Patients with HER2-Positive Metastatic Breast Cancer

On April 17, the U.S. Food and Drug Administration (FDA) approved Tukysa™(tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2+ breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Read FDA announcement.

Read full prescribing information. 

Posted 4/29/2020

Merck Broadens Patient Support and Assistance Programs as Part of Overall COVID-19 Relief Efforts

In response to the COVID-19 pandemic, Merck is focused on protecting the safety of its employees and their families, ensuring that its supply of medicines and vaccines reach its patients, contributing its scientific expertise to the development of antiviral approaches, and supporting healthcare providers and their communities. 

Read the press release for more information on Merck's response to COVID-19.

Posted 4/29/2020

How Pfizer Oncology Together Is Addressing Patient Needs

Pfizer recognizes the strain that the COVID-19 pandemic is placing on patients and healthcare providers around the world, and is working with governments, international NGOs, and U.S.-based not-for profit organizations to respond to this pandemic by donating much needed medications and vaccines and working to support front-line health workers.

Read Pfizer's full response to COVID-19. 

Posted 4/28/2020

COVID-19 Healthcare Professional Information Update

As critical and valued partners in the healthcare community in the U.S., Pfizer wanted to share its approach to the COVID-19 pandemic and changes it is making to best address your needs and those of the patients you serve. Pfizer is taking steps to ensure supply of its medicines and help halt the spread of this disease by developing antiviral therapies and, through a partnership, a potential vaccine for the COVID-19 virus.

Pfizer also recently announced a commitment of $40 million in medical and charitable cash grants to help address urgent needs of U.S. and global partners on the front lines of the pandemic.

Read Pfizer's full response to COVID-19. 

Posted 4/28/2020

BMS Patient Support Program Overview

In light of the developing situation around COVID-19, Bristol Myers Squibb would like to share immediate action they are taking to support the health and well-being of patients, customers, and employees during this time.

Bristol Myers Squibb is expanding its longstanding patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. The expanded program offers access to BMS medicine for free.

Read the expanded patient support program overview.

Posted 4/28/2020