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.
AbbVie is excited to announce its upcoming National Broadcast: New Evidence in First-Line AML and Exploring Outcomes with Fixed-Duration Treatment in CLL, taking place on Tuesday, November 10, Thursday, November 12, and Tuesday, November 17 across multiple time zones. You may tailor the program to your audience by selecting to have the data delivered by MDs or APPs.
Attendees will have the opportunity to learn directly from experts in AML and CLL. During this interactive presentation we will:
Click here for MDs, or here for APPs.
Posted on 10/28/2020
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.
Join professionals from across the country for an expert discussion on Lynparza (olaparib, AstraZeneca), and Lynparza + bevacizumab as maintenance monotherapy or combination therapy in advanced ovarian cancer: results from key clinical trials.
Members will be directed to a registration site which will give them the option to choose from all 6 webcasts
Members will be required to input their information to register for an event
Members can add the event to their calendar from the registration site or the registration confirmation email
Members will receive a reminder email 1 day and 30 minutes prior to the webcast
Details and registration.
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.
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
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.
Tafasitamab-cxix (Monjuvi®, Incyte), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
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(s).
Join a one-hour webcast to learn more about the usage of Tafasitamab-cxix (Monjuvi®) in treating your patients. For more information, click here.
Posted on 10/06/2020
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.