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.
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.
New Name for Takeda Oncology Patient Support Program
Effective May 18, 2020, Takeda Oncology has changed the name of its patient support program from "Takeda Oncology 1Point" to "Takeda Oncology Here2AssistTM". Patients and providers will continue to receive the same high level of comprehensive, personalized support.
Read corporate announcement.
Astellas' COVID-19 Pandemic Response
Amidst the unprecedented public health challenge, Astellas and its employees continue to contribute to securing the safety of patients and alleviating strain on healthcare resources during this critical time. This includes financial assistance to support local and global communities; policies focused on the well-being of its employees, healthcare professionals, and partners; employee mobilizations, and company-matched donations to humanitarian organizations. Additionally, Astellas is ensuring that patients have access to its medicines through its Pharma Support Solutions, which offers support to patients needing access and reimbursement assistance.
Read Astellas' full statement on the coronovirus.
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.
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.
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.
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:
Read the full FDA announcement here.
- 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.
Sanofi Genzyme's CareASSIST Patient Assistance Program
In response to COVID-19, Sanofi Genzyme is committed to helping patients. Through its CareASSIST Patient Assistance Program, eligible patients will receive assistance with access and support for their prescribed treatment.
Read the summary on the CareASSIST program.