Industry News Archive

  • 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



    • 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



    • myBeiGene™ Patient Support

      The myBeiGene patient support offers a customized and comprehensive support program designed to help guide and assist patients during treatment.

      For more information or to enroll, click here

      Posted 06/26/20



    • 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



    • FDA Approves Cyramza for First-Line Treatment of Metastatic EGFR-Mutated NSCLC

      On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab injection, 10 mg/mL solution (Cyramza®, Eli Lilly and Company) in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. With this approval, cyramza has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers.

      Read the press release

      Posted 6/22/2020




    • FDA Approves Tabrecta for Metastatic NSCLC with METex14

      On May 6, 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) approved TabrectaTM (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

      Read corporate press release

      Posted 6/22/2020



    • Pfizer Oncology Personalized Support

      At Pfizer Oncology Together, patient support is at the core of everything they do. From helping to identify financial assistance options to connecting patients to resources for emotional support, the needs of patients prescribed Pfizer Oncology medications are a top priority.

      Pfizer Oncology Field Reimbursement Managers (FRMs) can help address challenging or urgent Pfizer Oncology patient access cases. Click here for the FRM contact in Kansas.
       
      Posted 6/22/2020



    • FDA Approves Pembrolizumab for Treatment of TMB-H Solid Tumors

      On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

      On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab.

      Read the FDA announcement.

      Posted 6/17/2020




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