Industry News

  • FDA Approves Venetoclax Plus Obinutuzumab for CLL and SLL

    On May 15, AbbVie Inc. and Genentech Inc. announced that the U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA had previously granted Breakthrough Therapy designation to this chemotherapy-free combination.

    Read the Genentech press release    .

    Posted 5/15/2019


  • 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 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 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 Pemetrexed for Metastatic NSCLC

    On January 31, the U.S. Food and Drug Administration (FDA) approved pemetrexed for injection (Alimta, Eli Lilly and Company) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

    Read the Eli Lilly and Company press release here.

    Posted 1/31/2019


  • 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 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



  • 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 Unique HCPCS Code for Imfinzi

    Effective for dates of services on or after January 1, 2019, the following code can be used to identify Imfinzi (durvalumab) when billing across settings of care as noted in the Medicare Program: Changes to Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System and Quality Reporting Program:

    • J9173: Injection, durvalumab, 10 mg (APC 9492, SI G, Payment Rate $73.971*)
    * The payment rate is the average sales price (ASP) per 10mg of Imfinzi as documented by the CMS Hospital Outpatient PPS Addendum A. Effective from January 1, 2019 through March 31, 2019.

    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.

    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



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