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Industry News Archive

  • 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


  • FDA Approves Ibrutinib Plus Obinutuzumab for CLL/SLL

    On January 28, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica, Janssen and Pharmacyclics) in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

    Read the Janssen press release here.

     Posted January 28, 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 Pembrolizumab for Merkel Cell Carcinoma

    On December 19, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

    Read the FDA press release here.

    Posted 12/19/2018



  • CMS Assigns New J-Codes for Rituxan and Rituxan Hycela

    Effective January 1, 2019, the Centers for Medicare & Medicaid Services (CMS) has assigned new J-codes for Rituxan and Rituxan Hycela (Genentech, Inc.):
    • J9312: Injection, rituximab, 10 mg (replaces J-code J9310)
    • J9311: Injection, rituximab 10 mg and hyaluronidase
    These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements.

    Read more about the new J-codes for Rituxan and Rituxan Hycela here.

    Posted 12/7/2018


  • FDA Approves Atezolizumab for Metastatic NSq NSCLC

    On December 6, 2018, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.

    Read FDA announcement.

    Posted 12/7/2018


  • FDA Approves Gilteritinib for Acute Myeloid Leukemia

    On November 28, the Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma US Inc.) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

    The FDA also approved an expanded indication for a companion diagnostic, to include use with gilteritinib. The LeukoStrat CDx FLT3 Mutation Assay, (Invivoscribe Technologies, Inc.) is used to detect the FLT3 mutation in patients with AML.

    Read the full FDA press release here.

    Posted 11/28/2018



  • FDA Approves Venetoclax for Acute Myeloid Leukemia

    On November 21, the Food and Drug Administration granted accelerated approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

    Read the full FDA press release here.

    Posted 11/26/18



  • FDA Approves Glasdegib for Acute Myeloid Leukemia

    On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

    Read the full FDA press release here.

    Posted 11/26/2018


  • FDA Approves Pembrolizumab for Hepatocellular Carcinoma

    On November 9, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

    Read the Merck press release here.

    Posted 11/12/2018



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