Visit the ACCC COVID-19 Resource Center & Discussion Group for Insights on Providing Optimal Patient Care During the Pandemic.
Log in

Industry News Archive

  • FDA Grants Accelerated Approval to Lurbinectedin for Metastatic SCLC

    On June 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

    Read the FDA announcement.

    Posted 6/16/2020



  • FDA Approves HPV Vaccine Gardasil 9 for Prevention of Certain Head & Neck Cancers

    On June 12, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.

    Read the corporate press release.

    Posted 6/15/2020



  • CMS Issues Product-Specific J-code for Adakveo®

    Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg.

    The new and unique J-code replaces all previous HCPCS codes for crizanlizumab-tmca (Adakveo®, Novartis) for IV Infusion 10 mg/mL. The permanent J-code is used by all payer types.

    Please note: For dates of service before July 1, 2020, use either J3490 (unclassified drugs, all sites of care) or J3590 (unclassified biologics, all sites of care). For dates of service between April 1, 2020, and June 30, 2020, some payers may allow the use of C9053 (injection, crizanlizumab-tmca, 1 mg, hospital outpatient).

    See full prescribing information.

    Posted 6/12/20



  • FDA Approves Nivolumab for Previously Treated Advanced Esophageal SCC

    On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

    Read the FDA announcement.

    Posted 6/11/2020



  • Imbruvica® + Rituximab vs. FCR National Broadcast

    Redefining Approaches in Frontline Chronic Lymphocytic Leukemia (CLL) Treatment     

    Wednesday, June 17
    7:30 PM ET and 9:30 PM ET
    6:30 PM and 8:30 PM CT
    4:30 PM and 6:30 PM PT

    Register today to participate in a national broadcast: Imbruvica® + Rituximab vs. FCR: Data From a Head-to-Head Trial in 1L CLL/SLL. For details or to register, click here


    Read corporate announcement.

    6/09/2020



  • FDA Approves Atezolizumab for Adult Patients with Metastatic NSCLC

    On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®, Genentech), as a single agent, for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1–stained ≥50% of tumor cells [TC ≥50%] or PDL1–stained tumor-infiltrating immune cells [IC] covering ≥10% of the tumor area [IC ≥10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. 

    Read corporate announcement.

    Read prescribing information

    Posted 6/5/2020



  • FDA Approves Atezolizumab + Bevacizumab for Previously Untreated Advanced HCC

    On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab in combination with bevacizumab (Tecentriq and Avastin, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

    Read full FDA announcement

    Tecentriq prescribing information and billing/coding for HCC.

    Avastin prescribing information and billing/coding for HCC.

    Posted 6/2/2020



  • FDA Approves Nivolumab+Ipilimumab Combo as 1st Line Treatment for Metastatic NSCLC

    On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo, Bristol Myers Squibb Co.) plus ipilimumab (Yervoy, Bristol Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

    Read full FDA announcement.

    Posted May 27, 2020



  • FDA Approves Pomalidomide for Patients with AIDS-Related KS

    On May 14, 2020, the U.S. Food and Drug Administration (FDA) approved pomalidomide (Pomalyst®, Bristol Myers Squibb) capsules for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. 


    Read corporate announcement.


    Posted 5/26/2020



  • FDA Approves Brigatinib for ALK-Positive Advanced NCSLC

    On May 22, 2020, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

    On the same day, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic for brigatinib.

    Read full FDA announcement.

    Posted 5/26/2020




1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
hsco-hawaii.com
Email Us