Industry News Archive

  • 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.



  • National Broadcast: New Evidence in First-Line AML and Exploring Outcomes with Fixed-Duration Treatment in CLL

    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:

    • Recognize Venclexta as a BCL-2 inhibitor for 1L AML, and 1L and R/R CLL.
    • Review the phase 3 efficacy and safety outcomes of Venclexta + azacitidine from the pivotal VIALE-A study for patients with 1L AML, ineligible for intensive induction chemotherapy due to age or comorbidities.
    • Explore the efficacy and safety outcomes of Venclexta's chemo-free, fixed duration CLL regimens.

    Click here for MDs, or here for APPs.

    Posted on 10/28/2020



  • 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.

    Posted 10/19/2020



  • 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.

    Posted 10/15/2020


  • Webcast for Lynparza PAOLA-1 Launch

    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.

    Important Notes

    • 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.



  • clonoSEQ Receives FDA Clearance for MRD Assessment in CLL

    On August 5, 2020, clonoSEQ® (Adaptive Biotechnologies®), a next-generation sequencing assay that detects and monitors measurable residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL), received U.S. Food and Drug Administration (FDA) clearance for MRD assessment in blood and bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is covered by Medicare for these indications. 

    Read the Press Release. For prescribing information and test limitations view the clonoSEQ Technical Summary.



  • 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. 

    Posted 10/02/2020



  • 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.

    Posted 10/02/2020




1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
txsco.com
Email Us