FDA Accepts for Priority Review Cemiplimab-rwlc for Advanced NSCLC
On Thursday, October 29, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.
The target action date for the FDA decision is February 28, 2021.
Read press release.
Posted on 10/29/2020.
FDA Approves Venetoclax in Combination for Untreated AML
On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to Venclexta® (venetoclax) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.
Venetoclax was initially granted accelerated approval for this indication in November 2018.
Read Roche's announcement and the FDA announcement.
FDA Approves Expanded Indication of Pembrolizumab for R/R cHL
On October 15, 2020, the U.S. Food and Drug Administration (FDA) approved an expanded label for Keytruda® (pembrolizumab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory cHL after frontline therapy.
Read Merck's press release and the FDA announcement.
Know Your State Interactive Tool
Know Your State Interactive Tool (Janssen), provides state-specific access and affordability options to help patients learn about medication access and affordability options. Navigation is easy and tailored to each state.
Click here to download the interactive PDF. For the best navigation experience, please open the file with Adobe Acrobat Reader.
Topics within the tool include:
• Advocacy Connector
• Biosimilar Legislation
• Continuity of Care
• Low-Income Subsidy (LIS) Eligibility Information
• Medicaid Expansion
• National Foundations and other
• Oral Parity Laws
• Standard Prior Authorization (PA) Forms
• State Health Insurance Assistance Programs (SHIPs)
• State Legislature Resources
• State Pharmaceutical Assistance Programs (SPAPs)
If you would like a demonstration of the tool, please contact Dave Cecil, MBA, Healthcare Policy and Advocacy Director.
Ibrutinib for the Treatment of Adult Patients with CLL/SLL
Ibrutinib (Imbruvica®, Pharmacyclics) is a once-daily oral therapy indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Ibrutinib is also indicated for the treatment of adult patients with CLL/SLL with 17p deletion.
Read efficacy study and prescribing information.
To help guide and assist patients during treatment, Pharmacyclics the YOU&iTM Support Program, which provides information on insurance coverage and out-of-pocket costs, and what to expect while on treatment.
Posted on 10/07/2020
myBeiGene Patient Support for Zanubrutinib
Zanubrutinib (Brukinsa™, BeiGene) is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. For prescribing information click here, or here for the Dosing and Administration Guide.
To help guide and assist patients during treatment, Beigene has developed a customized and comprehensive support program. The myBeiGene Patient Support program is staffed with nurses who have prior experience working with oncology patients. Practices and their patients get a dedicated Oncology Nurse Advocate assigned to them, and comprehensive patient support, including connecting patients to helpful resources that can address their personal needs.
Posted on 10/07/2020
Exelixis Access Services® EASE
Exelixis Access Services® (EASE) provides a variety of support to help your patients get started on cabozantinib (Cabometyx®)as soon as possible. EASE can help meet the unique needs of your patients and practice at each step along the access journey.
Cabozantinib Prescribing Information and Resources
Exelixis has issued prescribing information for cabozantinib (Cabometyx®), which is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib as well as a series of resources that you can utilize in your practice.
Access Prescribing Information and Resources.
FDA Approves Nivolumab + Ipilimumab Immunotherapy Treatment for Mesothelioma
On October 2, 2020 the U.S. Food and Drug Administration (FDA) approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.
Read the FDA Announcement.
Read the Bristol Myers Squibb Announcement.
FDA Approves Two Liquid Biopsy Companion Diagnostics for Osimertinib
On August 7, the U.S. Food and Drug Administration (FDA) approved FoundationOne® Liquid CDx and Guardant360® CDx as next generation sequencing based liquid biopsy companion diagnostics for osimertinib (Tagrisso®) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
See full prescribing information.
About FoundationOne® Liquid CDx.
About Guardant360® CDx.