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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
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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
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FDA Approves Nivolumab+Ipilimumab Combo as 1st Line Treatment for Metastatic NSCLC
On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol Myers Squibb Co.) plus ipilimumab (Yervoy, Bristol Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Read full FDA announcement.
Posted May 27, 2020
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FDA Approves Pomalidomide for Patients with AIDS-Related KS
On May 14, 2020, the U.S. Food and Drug Administration (FDA) approved pomalidomide (Pomalyst®, Bristol Myers Squibb) capsules for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate.
Read corporate announcement.
Posted 5/26/2020
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FDA Approves Brigatinib for ALK-Positive Advanced NCSLC
On May 22, 2020, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
On the same day, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic for brigatinib.
Read full FDA announcement.
Posted 5/26/2020
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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
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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
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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
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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.
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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.
Posted 5/13/2020