FDA Approves Atezolizumab for Adult Patients with Metastatic NSCLC

On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq^®, Genentech), as a single agent, for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1–stained ≥50% of tumor cells [TC ≥50%] or PDL1–stained tumor-infiltrating immune cells [IC] covering ≥10% of the tumor area [IC ≥10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. 

Read corporate announcement.

Read prescribing information. 

Posted 6/5/2020

FDA Approves Atezolizumab + Bevacizumab for Previously Untreated Advanced HCC

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

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 the corporate press release.

Read the Lynparza PAOLA-1 Testing Medical Policy Considerations.

Posted 5/21/2020

FDA Approves Olaparib for HRR Gene-Mutated mCRPC

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

FDA Approves Atezolizumab for 1st-Line Treatment in Some Advanced NSCLC

On May 18, 2020, the U.S. Food and Drug Administration approved atezolizumab (Tecentriq^®) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations.

On the same day, the FDA also approved the VENTANA PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device for selecting patients with NSCLC for treatment with atezolizumab.

Read the full FDA announcement. 

Posted 5/19/2020

Merck's Response to COVID-19

During this unprecedented time, Merck is committed to ensuring its medicines and vaccines reach its patients and customers. This includes supporting patients who might need more help today with their medications, including those who are unemployed or have lost insurance coverage due to the COVID-19 pandemic.

To learn about what support options may be available, visit Merck's Access and Patient Assistance information page.

For more details about Merck’s response to the coronavirus, visit its COVID-19 information page.

Posted 5/13/2020

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 Niraparib for Frontine Maintenance of Advanced Ovarian Cancer

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