Share

    


In This Section

Home / News & Media / Oncology Newsfeed

Oncology Newsfeed

  • Decreased Survival in Clinical Trials for Some Patients Receiving Keytruda or Tecentriq as Monotherapy for Urothelial Cancer

    On May 18, 2018, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals, oncology clinical investigators, and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) 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).

    In two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130), the Data Monitoring Committees’ (DMC) early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy. There was no change in the adverse event profile of Keytruda or Tecentriq. Both Merck, manufacturer of Keytruda, and Genentech, manufacturer of Tecentriq, have stopped enrolling patients whose tumors have PD-L1 low status to the Keytruda or Tecentriq monotherapy arms per the DMCs’ recommendations.

    The clinical trials compare platinum-based chemotherapy combined with Keytruda or Tecentriq to platinum-based chemotherapy alone. Both trials enrolled a third arm of monotherapy with Keytruda or Tecentriq to compare to platinum-based chemotherapy alone. The monotherapy arms remain open only to patients whose tumors have PD-L1 high status. The combination arms and the chemotherapy arms of both studies also remain open. The FDA is reviewing the findings of the ongoing clinical trials and will communicate new information as necessary.

    Both Keytruda and Tecentriq are currently approved under accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing chemotherapy, irrespective of PD-L1 status. Patients taking Keytruda or Tecentriq for other approved uses should continue to take their medication as directed by their healthcare professional.

    Healthcare professionals should be aware that the populations enrolled in the ongoing clinical trials were eligible for platinum-containing chemotherapy, and therefore differ from those enrolled in the trials that led to the accelerated approvals of both Keytruda and Tecentriq in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. FDA recommends providers select patients for the treatment of locally advanced or metastatic urothelial cancer using the criteria described in Section 14 of each label. These criteria supported the approvals for Keytruda and Tecentriq for initial monotherapy in cisplatin-ineligible patients. Keytruda and Tecentriq are also currently approved by the FDA for the treatment of multiple types of other cancers.

    Patients should talk to their doctor if they have questions or concerns about either drug.

    Health care professionals and patients are encouraged to report any adverse events or side effects related to the use of these products and other similar products to FDA’s MedWatch Adverse Event Reporting program.

    Keytruda Prescribing Information 
    Tecentriq Prescribing Information

    Access FDA announcement.

    Posted 5/21/2018



  • FDA Approves Drug for Thrombocytopenia in Adults with Chronic Liver Disease

    On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.

    Read the full FDA announcement here.

    Posted 5/21/2018



  • AUA Updates Guideline on Castration-Resistant Prostate Cancer

    On May 17, 2018, the American Urological Association (AUA) announced updates to its castration-resistant prostate cancer (CRPC) guideline. The guideline was updated to incorporate new published research related to the treatment of patients with asymptomatic non-metastatic CRPC.

    Read the newly amended guideline here.

    Posted 5/18/2018


  • FDA Approves Biosimilar to Epoetin Alfa for Anemia

    On May 15, 2018, the Food and Drug Administration approved epoetin alfa-epbx (Retacrit, Hospira Inc.) as a biosimilar to epoetin alfa (Epogen/Procrit, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

    Read the FDA announcement here.

    Posted 5/15/2018


  • HHS Issues Formal RFI for Drug Pricing Blueprint

    On May 14, the Department of Health and Human Services (HHS) issued a formal request for information (RFI) regarding the Trump Administration’s proposed drug pricing blueprint. HHS seeks “all suggestions to improve the affordability and accessibility of prescription drugs, including reflections and answers to questions not specifically asked.” Questions specifically posed by HHS are:

    • What other regulations or government policies may be increasing list prices, net prices, and out-of-pocket drug spending?
    • What other policies or legislative proposals should HHS consider to lower drug prices while encouraging innovation?
    • What data or evidence should HHS consider when developing proposals to lower drug prices?
    • HHS is actively working to reduce regulatory burdens. To what extent do current regulations or government policies related to prescription drug pricing impose burden on providers, payers, or others?
    • To what extent do the planned actions described in this document impose burden, and do these burdens outweigh the benefits?

    ACCC will be submitting comments, but we also encourage our member programs to weigh in on this important document. Comments must be submitted on or before July 15, 2018. To submit electronically, go to http://www.regulations.gov.

    Posted 5/14/2018


  • President Trump Unveils Blueprint to Lower Drug Prices

    On Friday, May 11, President Trump and U.S. Department of Health and Human Services Secretary Alex M. Azar II announced the administration's plan to lower drug prices.

    Access "American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs."

    ACCC is continuing to look at the policies' implications for our members and their patients. Stay tuned for updates.

    Posted 5/11/2018



  • CMS Releases Rural Health Strategy

    On May 8, 2018, the Centers for Medicare & Medicaid Services (CMS) announced the launch of its first Rural Health Strategy. The strategy is intended to address access to quality, affordable healthcare in rural communities, the viability of rural hospitals, and the effects of CMS rules and regulations on healthcare in rural areas.

    Read the full Rural Health Strategy here, and read the fact sheet here.


    Posted 5/8/2018



  • USPSTF Issues Final Recommendation on Screening for Prostate Cancer

    On May 8, 2018, the U.S. Preventive Services Task Force (USPSTF) released a final recommendation statement and evidence summaries on screening for prostate cancer. The USPSTF final recommendation provides clinicians and patients with important new information about the benefits and harms of prostate-specific antigen (PSA)-based screening. 

    For men 55 - 69 years of age, the USPSTF final recommendation calls for informed individual decision-making based on the individual's values and specific clinical circumstances. This is a C recommendation.

    The USPSTF recommends against PSA-based screening for prostate cancer in men age 70 and older.

    Read the USPSTF Recommendation Statement and access the evidence summary and FAQs.

    Posted May 8, 2018


  • FDA Approves Daratumumab for Newly Diagnosed, Transplant Ineligible MM Patients

    On May 7, 2018, the Food and Drug Administration approved daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).

    Read the Johnson & Johnson press release here.

    Posted 5/8/2018


  • FDA Approves Dabrafenib and Trametinib for Treatment of Thyroid Cancer

    On May 4, 2018, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis Pharmaceuticals Corp.) and trametinib (Mekinist, Novartis Pharmaceuticals Corp.), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).

    Read the full FDA announcement here.

    Posted 5/1/2018