Industry News Archive

  • FDA Approves Keytruda for Patients with Unresectable or Metastatic MSI-H or dMMR CRC

    On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

    MSI-H/dMMR testing is required prior to initiating treatment with Keytruda in these patients. For the MSI-H/dMMR indication, select patients for treatment with Keytruda as a single agent based on MSI-H/dMMR status in tumor specimens. An FDA-approved test for the detection of MSI-H or dMMR is not currently available.

    Read prescribing information and medication guide

    Posted 7/17/2020



  • FDA Approves Pembrolizumab for Patients with Recurrent or Metastatic cSCC

    On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) injection 100 mg for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. 

    Read FDA announcement and prescribing information

     

    Posted 7/14/2020



  • FDA Approves Phesgo™ Injection for Subcutaneous Use

    On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo, Genentech) injection, for subcutaneous use.

    Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for:

      Phesgo™ is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

      Read corporate announcement.

      Billing and coding sheet.

      Prescribing information.

      Posted 7/14/2020



    • FDA Approves Decitabine + Cedazuridine Oral Combo for Adult MDS

      On July 7, 2020, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS) including the following:

      • previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and
      • intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
      Read the FDA announcement.

      Posted 7/7/2020


    • Enhertu Receives Permanent J-Code

      Effective July 1, 2020, ENHERTU® (fam-trastuzumab deruxtecan-nxki) has a permanent j-code: J9358. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting.

      For full prescribing information, click here

      Posted 7/7/20



    • Update: COVID-19 Emergency Food Assistance Grant Amount Change

      Due to increasing demand for the program’s financial assistance, the individual grant award amount has been changed to $300 effective immediately. This adjustment will allow thousands of additional patients to receive meaningful financial support for nutritional needs while maximizing the reach of available funding as the number of people impacting by COVID 19 continues to accelerate.

      To date, the COVID-19 Emergency Food Assistance Program has helped more than 13,000 patients, including 1,000 emergency food deliveries made and over 12,000 financial assistance grants being provided to patients in all 50 states.  

      This innovative program is a collaboration between Team Rubicon (TR) and Patient Advocate Foundation (PAF) and provides emergency food delivery and financial assistance to people living with cancer, multiple sclerosis, and rheumatoid arthritis.

      Who is Eligible?

      Patients with cancer, multiple sclerosis or rheumatoid arthritis who have trouble accessing or affording food or other nutritional needs due to COVID-19, with eligibility established at the point of application in most cases.

      For more information, including application instructions, click here.  

      Posted 7/2/2020



    • FDA Approves Pembrolizumab for First-line Treatment of Metastatic MSI-H or dMMR CRC

      On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

      Read FDA announcement.

      Posted 6/30/2020



    • FDA Approves Pembrolizumab for Recurrent or Metastatic cSCC

      On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

      Read the FDA announcement.

      Posted 6/24/2020



    • Taiho Oncology Patient Support Program

      Taiho Oncology Patient Support offers personalized services to give patients, caregivers, and healthcare professionals the help they need in getting started with Taiho Oncology Products. This includes insurance verification, help with medication costs, and treatment plan support.

      Learn more

      Posted 6/22/2020



    • Lonsurf Efficacy Flashcard

      Lonsurf®  (FTD/TPI, Taiho Oncology) is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.


      Read efficacy and safety information

      Posted 6/22/2020




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