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Industry News Archive

  • FDA Approves Alpelisib for Metastatic Breast Cancer

    On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

    Read FDA announcement
    .

    Posted 5/28/2019


  • FDA Approves Ruxolitinib for Acute Graft-Versus-Host Disease

    On May 24, Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has approved ruxolitinib (Jakafi) for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) for adults and pediatric patients ≥12 years of age. It is the first and only FDA-approved treatment for this indication.

    Read the Incyte press release here.

    Posted 5/24/2019


  • FDA Approves Avelumab Plus Axitinib for Advanced RCC

    On May 14, Pfizer Inc. announced that the FDA has approved avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). A Phase III study showed that the combination significantly lowered risk of disease progression or death by 31 percent and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib.

    Read the Pfizer press release.

    Posted 5/15/2019



  • 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


  • 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 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 Pembrolizumab for Melanoma

    On February 15, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

    Read the FDA press release here.

    Posted 2/19/2019


  • Medicare Coverage Established for MRD Testing for ALL, Multiple Myeloma

    On January 17, Adaptive Biotechnologies announced that Palmetto GBA has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing testing.

    Read the Adaptive Biotechnologies press release here
    .

    Posted 1/23/2019


  • FDA Approves Olaparib for Ovarian, Fallopian, Peritoneal Cancers

    On December 19, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients with gBRCAm advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.

    Read the FDA press release here
    .

    Posted 12/19/2018




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