Industry News

  • FDA Approves Talazoparib for gBRCAm HER2- Breast Cancer

    On October 16, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.) for the treatment of patients with deleterious or suspected germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on the use of the FDA-approved companion diagnostic BRACAnalysis CDx (Myriad Genetics, Inc.).

    Read the full FDA press release here.

    Posted 10/16/18


  • FDA Expands Approval of HPV Vaccine to People Aged 27 to 45

    On October 5, the U.S. Food and Drug Administration expanded the approved use of Gardasil 9 (Human Papillomavirus [HPV] 9-valent Vaccine, Recombinant, Merck & Co.) to include individuals aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by nine types of HPV. Gardasil 9 was previously approved for individuals aged 9 through 26 years.

    Read the full FDA press release here.

    Posted 10/8/2018


  • Imfinzi Demonstrates Overall Survival Benefit in Stage III Lung Cancer

    AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi (durvalumab) during the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Toronto, Canada. Results were published simultaneously in the New England Journal of Medicine.

    Results from the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following chemoradiation showed that Imfinzi significantly improved OS, the second primary endpoint of the trial, compared to placebo regardless of PD-L1 expression, reducing the risk of death by 32%.

    Read the full corporate press release here.

    Posted 9/28/18



  • FDA Approves Dacomitinib for Metastatic NSCLC

    On September 27, the Food and Drug Administration approved dacomitinib tablets (Vizimpro, Pfizer Inc.) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

    Read the full FDA press release here.

    Posted 9/28/18


  • FDA Approves New Treatment for Hairy Cell Leukemia

    On September 13, the Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxiti, AstraZeneca) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.

    Read the full FDA press release here.

    Posted 9/13/2018


  • FDA Approves Ibrutinib Plus Rituximab for Rare Blood Cancer

    On August 27, AbbVie announced that the FDA has approved ibrutinib (Imbruvica) (Pharmacyclics, LLC) plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). This approval represents the first and only chemotherapy-free combination treatment specifically indicated for the disease.

    Read the full AbbVie corporate press release here.

    Posted 8/27/2018


  • FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC

    On August 17, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.

    Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.

    Read the full FDA announcement here.

    Posted 8/20/2018



  • FDA Approves Nivolumab for Previously Treated SCLC Patients

    On August 17, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR).

    Read the BMS press release here.
    Read the FDA announcement here.

    Posted 8/17/2018


  • FDA Approves Ribociclib in Combination for Advanced, Metastatic Breast Cancer

    On July 18, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

    The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

    Read the full FDA press release here.

    Posted 7/18/18


  • CMS Posts MIPS Final Scores, Performance Feedback for Review

    On July 2, 2018, CMS announced that participants in the Merit-based Incentive Payment System (MIPS) in 2017 could review their MIPS final score and performance feedback on the Quality Payment Program website. The payment adjustment received in 2019 is based on this final score. A positive, negative, or neutral payment adjustment will be applied to the Medicare paid amount for covered professional services furnished under the Medicare Physician Fee Schedule in 2019.

    MIPS eligible clinicians or groups (along with their designated support staff or authorized third-party intermediary), including those who are subject to the APM scoring standard, may request for CMS to review their performance feedback and final score through a process called targeted review. 

    If you believe an error has been made in your MIPS payment adjustment calculation, you can request a targeted review until September 30, 2018. The following are examples of circumstances in which you may wish to request a targeted review:

    • Errors or data quality issues on the measures and activities you submitted
    • Eligibility issues (e.g., you fall below the low-volume threshold and should not have received a payment adjustment)
    • Being erroneously excluded from the APM participation list and not being scored under APM scoring standard
    • Not being automatically reweighted even though you qualify for automatic reweighting due to the 2017 extreme and uncontrollable circumstances policy

    You can access your MIPS final score and performance feedback and request a targeted review by:

    • Going to the Quality Payment Program website
    • Logging in using your Enterprise Identity Management (EIDM) credentials; these are the same EIDM credentials that allowed you to submit your MIPS data. Please refer to the EIDM User Guide for additional details.

    CMS has posted new resources on CMS.gov to help eligible clinicians and groups understand their Merit-based Incentive Payment System (MIPS) final score, performance feedback, and payment adjustment, as well as the targeted review process. The new resources include:

    For more information, visit the Quality Payment Program Resource Library on CMS.gov to review new and existing Quality Payment Program resources, or contact the Quality Payment Program at QPP@cms.hhs.gov or 1-866-288-8292 (TTY: 1-877-715-6222).

    Posted 7/2/2018


  • FDA Restricts Use of Keytruda and Tecentriq for Urothelial Cancer

    On June 20, 2018, the FDA announced that it was restricting the use of Keytruda (pembrolizumab) and Tecentriq (atezolizumab) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

    This restriction results from decreased survival associated with the use of Keytruda or Tecentriq as monotherapy compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

    Read the full FDA announcement here.

    Posted 6/21/2018


  • Pfizer’s Biosimilar Retacrit® Receives Q-Codes

    On May 15, 2018 the U.S. Food and Drug Administration approved Retacrit (epoetin alfa-epbx), a biosimilar to Epogen®/Procrit® (epoetin alfa). Retacrit is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) in the United States and is approved for the same indications as Epogen/Procrit.

    CMS has granted two Q-codes for Retacrit effective July 1, 2018:

    Q5105: Injection, epoetin alfa, biosimilar, (Retacrit) (for esrd on dialysis), 100 units

    Q5106: Injection, epoetin alfa, biosimilar, (Retacrit) (for non-esrd use), 1000 units

    View Codes on CMS Website



  • FDA Approves Pembrolizumab for Treatment of PMBCL

    On June 13, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.

    Read the FDA press release here.

    Posted 6/19/2018


  • FDA Approves Pembrolizumab for Advanced Cervical Cancer

    On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

    Read the full FDA press release here.

    Posted 6/13/2018


  • FDA Approves Venetoclax for CLL, Small Lymphocytic Lymphoma

    On June 8, 2018, the Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

    Read the full FDA announcement here.

    Posted 6/11/2018



  • Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA

    Read Press Release


  • CMS Begins Mailing Out New Medicare Cards

    The Centers for Medicare & Medicaid Services (CMS) has begun mailing its newly-designed Medicare cards with new Medicare Beneficiary Identifiers to newly eligible and current Medicare beneficiaries. Cards will be sent out on a rolling basis throughout 2018 to fulfill the CMS requirement to remove Social Security Numbers from all Medicare cards by April 2019.

    CMS will host a special Open Door Forum on April 5, 12:30 – 1:30 PM EST, to share updates about the new Medicare card mailing, information on how people with Medicare can look up their new Medicare card number or print a replacement card, and updates on resources for partners. To participate, visit https://webinar.cms.hhs.gov/r51uia09fgq/ and use the following information:

    • Dial-In Number: 1-800-837-1935
    • Conference ID #: 7065199

    Check cms.gov/newcard often for the most up-to-date information.

    Posted 4/4/2018



  • IMBRUVICA® Approved in New Formulation as One Pill, Once Daily

    More Information


  • Trump Administration Announces MyHealthEData Initiative

    Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma has announced the administration's new MyHealthEData, an initiative that aims to give Americans more complete access to their healthcare data. She made the announcement in an address on March 6, 2018, at the Healthcare Information and Management Systems Society (HIMSS) Annual Conference in Las Vegas. The government-wide initiative is being led by the White House Office of American Innovation with participation from the Department of Health and Human Services, including CMS; Office of the National Coordinator for Health Information Technology (ONC); the National Institutes of Health; and the Department of Veterans Affairs. 

    As part of MyHealthEData announcement, CMS also announced that the agency intends to "overhaul" the EHR Incentive Programs to "refocus the programs on interoperability and to reduce the time and cost required" for providers to meet requirements. 

    In her remarks, Administrator Verma also described Medicare's Blue Button 2.0 - a tool that would allow Medicare beneficiaries to access and their personal health data in a "universal digital format."  

    As part of this initiative, the administration is also calling on healthcare insurers to follow suit and give patients access to their claims data in a digital format. 

    The administration is still developing a timeline for the initiative, Verma said in an interview with Bloomberg BNA. 

    Read the CMS press release.
    Read the CMS fact sheet. 

    Posted 3/7/18




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