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Industry News Archive

  • FDA Approves Ramucirumab for HCC

    On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.

    Read the FDA press release here.

    Posted 5/10/2019


  • FDA Approves Pembrolizumab + Axitinib for Advanced Renal Cell Carcinoma

    On April 19, the FDA approved pembrolizumab (Keytruda, Merck & Co. Inc.) plus axitinib (Inlyta, Pfizer Inc.) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

    Read the full FDA press release here.

    Posted 4/22/2019


  • FDA Expands Pembrolizumab Indication to Include First-Line NSCLC Treatment

    On April 11, 2019, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.

    Read the FDA press release here.

    Posted 4/12/2019


  • FDA Expands Palbociclib Use to Include Male Breast Cancer Patients

    On April 4, the U.S. Food and Drug Administration extended the indication of palbociclib (Ibrance, Pfizer Inc.) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

    Read the full FDA press release here.

    Posted 4/5/2019


  • HCPCS Assigns J-Code and ASP for Imfinzi

    Imfinzi (durvalumab) has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and average sales price (ASP) by the Centers for Medicare & Medicaide Services (CMS). The following code can be used to identify Imfinzi when billing across settings of care:

    • J9173: Injection, durvalumab, 10 mg (vial size 500mg/10 mL, billing unit 50 units, NDC 0310-4611-50)
    • J9173: Injection, durvalumab, 10 mg (vial size 120mg/2.4 mL, billing unit 12 units, NDC 0310-4500-12)
    Each provider is responsible for ensuring all coding is accurate and documented in the medical record based on the condition of the patient. The use of this information does not guarantee reimbursement.  Healthcare providers are encouraged to contact payers to confirm code adoption and approved usage prior to submitting claims. Imfinzi is listed in the April 2019 ASP Pricing File:

    • J9173: Inj., durvalumab, 10 mg (HCPCS code dosage 10MG, payment limit $73.778).

    Posted 12/19/2018


  • FDA Approves Atezolizumab for Small Cell Lung Cancer

    On March 19, the FDA approved atezolizumab (Tecentriq®, Genentech) in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

    Read the Roche press release here.
    Read the FDA press release here.
    Download the Tecentriq ES-SCLC Day 1 Letter here.

    Posted 3/19/2019


  • FDA Approves Trastuzumab-qyyp as Biosimilar to Herceptin

    On March 11, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera), a biosimilar to Herceptin, for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

    Read the Pfizer press release here.

    Posted 3/12/2019


  • FDA Approves Atezolizumab Plus Nab-paclitaxel for TNBC

    On March 8, the FDA approved atezolizumab (Tecentriq, Genentech Inc.) plus nab-paclitaxel (Abraxane, Celgene) for the frontline treatment of patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC).

    Read OncLive news coverage here
    .

    Posted 3/8/2019


  • FDA Approves Trastuzumab and Hyaluronidase-oysk for Breast Cancer

    On February 28, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use (Herceptin Hylecta, Genentech Inc.) for the treatment of HER2-overexpressing breast cancer.


  • FDA Approves Trifluridine and Tipiracil for Gastric/GEJ Adenocarcinoma

    On February 25, the U.S. Food and Drug Administration approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) for the treatment of adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

    Read the Taiho Oncology press release here.

    Posted 2/25/2019



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