May 15, 2019
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
May 13, 2019
On May 10, the U.S. Food and Drug Administration (FDA) released its final guidance to drug manufacturers with direction on what studies need to show the agency in how a biosimilar is interchangeable with a biologic. The healthcare community, and specifically, the oncology community, has called upon the FDA and Congress to increase the availability and competition of biosimilars. Read statement from acting FDA Commissioner Ned Sharpless, MD.
Posted 5/13/2019
May 10, 2019
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
May 3, 2019
On May 3, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (T-DM1) (Kadcyla, Genentech Inc.) for use as an adjuvant treatment option for patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (Herceptin) and chemotherapy. Read the TargetedOnc article here .
Posted 5/3/2019
May 3, 2019
On May 2, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. Read the FDA press release here .
Posted 5/3/2019
May 2, 2019
On May 2, the American Urological Association (AUA) released a new clinical guideline for the diagnosis and treatment of early-stage testicular cancer, the most common cancer among men aged 20 to 40. The new clinical guideline makes 45 recommendations, including recommendations for scrotal ultrasound, obtaining serum tumor markers, and sperm banking prior to orchiectomy. Read the AUA press release .
Read Diagnosis and Treatment of Early State Testicular Cancer: AUA Guideline (2019).
On April 30, AUA and the American Society for Radiation Oncology (ASTRO) announced updates to their joint clinical guideline on adjuvant and salvage radiotherapy after prostatectomy in patients with and without evidence of prostate cancer recurrence to include new published research related to adjuvant radiotherapy. Read the AUA press release .
Read Adjuvant and Radiotherapy after Prostatectomy: ASTRO/AUA Guideline .
Posted 5/2/2019
May 2, 2019
A new study by researchers from the American Cancer Society (ACS) finds that approximately 137 million adults in America (56 percent) reported having medical financial hardship in the past year. Highlights of the report include:
2017 ACCC Annual Achievement Award winner Barbara McAneny, MD, president of the American Medical Association, says of the study in the Los Angeles Times , "People are trying hard to do the right thing, but care is being prices out of their reach." Read the ACS press press release . Read the Los Angeles Times article .
Read "Prevalence and Correlates of Medical Financial Hardship in the USA" in the Journal of General Internal Medicine .
Posted 5/2/2019
April 25, 2019
The American Heart Association (AHA) has published a scientific statement in the journal Circulation outlining the need to develop and test cardio-oncology rehabilitation programs for patients at high risk for cardiac dysfunction during and after cancer treatment. The statement outlines the process for identifying at-risk patients and the infrastructure needed to address the unique exposures and complications related to cardiac rehabilitation. Read the AHA journal article here .
Posted 4/25/2019
April 23, 2019
On April 23, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for fiscal year (FY) 2020.
In the IPPS proposed rule, the agency proposes to:
The agency fact sheet specifically addresses CAR-T therapy in the context of applications for new technology add-on payments for FY 2020. In the proposed rule, CMS presents 17 new applications for new technology add-on payment for FY 2020, and proposes to continue the new technology add-on payments for 10 of the 13 technologies currently receiving the add-on payment (3 technologies will no longer be in their newness period in FY 2020). Two of the technologies CMS is proposing to continue payments for are types of chimeric antigen receptor (CAR) T‑cell therapy.
The ACCC policy team is analyzing the proposed rule and will provide a more in-depth analysis to members shortly.
Read the agency fact sheet . Access the proposed rule .
Posted 4/23/2019
April 22, 2019
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
April 17, 2019
The National Institutes of Health (NIH)/National Cancer Institute (NCI) have announced a funding opportunity RFA-CA-19-035 , titled "Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-Up Care (RO1 Clinical Trial Required)"
The Funding Opportunity Announcement (FOA) solicits applications that develop and test models of care for adult survivors of cancer who are transitioning from active treatment to follow-up care. Through this FOA, the NCI intends to support multi-level interventions that enhance communication, collaboration, and coordination among oncology and non-oncology providers to improve cancer survivor outcomes.
Interventions that focus on the needs of racial/ethnic minority or medically underserved adult survivors and/or those receiving care in community settings (including, but not limited to, community-based cancer centers) are not required but strongly encouraged. NCI seeks to fund applications that represent a broad spectrum of cancer survivors (e.g., variability in demographics, cancer type, clinical characteristics) and care delivery settings (e.g., community settings, integrated healthcare settings).
KEY DATES
Open Date (Earliest Submission Date): May 28, 2019
Letter of Intent Due Date(s): 30 days prior to the application due date
Application Due Date(s): June 28, 2019, by 5:00 PM local time of applicant organization.
DATE FOR PRE-APPLICATION WEBINAR for RFA-CA-19-035May 3, 20191:00 PM - 2:00 PM (ET)
On Friday, May 3, 2019 from 1:00 - 2:00 PM (ET), NCI will hold a pre-application webinar for RFA-CA-19-035 entitled "Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-up Care (R01 Clinical Trial Required)."
NCI staff members involved in this FOA will provide orientation and technical assistance to potential applicants to the above-referenced FOA by explaining the goals and objectives for the proposed FOA and answer questions from webinar attendees. Potential applicants are encouraged to submit their questions to NCIHDRP@mail.nih.gov by 12 pm ET on May 1, 2019.
To join the webinar, pre-registration is required through Webex . Specific webinar information will be provided upon registration.
Posted 4/17/19
April 17, 2019
The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have issued an updated practice guideline on the use of erythropoiesis-stimulating agents (ESAs) in cancer care, in which they state that the available literature suggests that biosimilars of epoetin alfa have similar efficacy and safety to reference agents. The update also suggests that both biosimilars and their references may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent. Read the ASCO and ASH press release here.Read the updated ESA guideline here.
Posted 4/17/2019
April 12, 2019
On April 12, the Food and Drug Administration granted accelerated approval to erdafitinib (Balversa, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The FDA also approved the therascreen FGFR RGQ RT-PCR Kit developed by Qiagen for use as a companion diagnostic for this therapeutic indication. Read the full FDA press release here.
Posted 4/12/2019
April 12, 2019
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
April 5, 2019
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
March 27, 2019
The U.S. Food and Drug Administration issued a proposed rule on March 27 that would make amendments to the regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 that seek to improve the quality of mammography services. The proposed rule would expand the information mammography facilities are required to provide to patients and healthcare professionals to allow for more informed medical decision-making, the agency said in a statement. It also modernizes mammography quality stands and strengthens the FDA’s ability to enforce regulations that apply to the safety and quality of mammography services.
Under the proposed rule, breast density information would be added to the mammography lay summary letter provided to patients and to the medical report provided to their referring healthcare professionals.
The amendments would also expand the information provided to healthcare professionals by proposing to codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for healthcare professionals those cases where cancer being mammographically evaluated for therapy are already known and identified.
Under the proposed regulations, both healthcare professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications, the agency said.
The proposed rule will be open for public comment for 90 days after publication. Read the FDA press release . View the proposed rule .
Posted 3/27/2019
March 19, 2019
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
March 14, 2019
On March 14, the Centers for Medicare & Medicaid Services (CMS) updated its Drug Spending Dashboards with data for 2017. The dashboards add information on manufacturers that are responsible for price increases and includes pricing and spending data for drugs across Medicare Parts B and D and Medicaid.
The dashboards focus on average spending per dosage unit for prescription drugs paid under Medicare Parts B and D and Medicaid, and tracks the change in average spending per dosage unit over time. Information is also provided on drug uses and clinical indications, so patients and physicians can compare the list prices of different medications for a given condition.
In 2017, total gross spending on prescription drugs was $154.9 billion in Medicare Part D, $30.4 billion in Part B, and $67.6 billion in Medicaid.
Click here to access the CMS Drug Spending Dashboards .
Posted 3/14/2019
March 12, 2019
On March 12, Health and Human Services Secretary Alex Azar told Congress that Norman "Ned" Sharpless, director of the National Cancer Institute (NCI), will become acting commissioner of the Food and Drug Administration (FDA), succeeding Scott Gottlieb. Gottlieb announced his April departure in the first week of March.
Doug Lowy, current NCI Deputy Director, will serve as acting director of the NCI upon Sharpless' transition to the FDA. Read news coverage from STAT here .
Posted 3/12/2019
March 12, 2019
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
March 8, 2019
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
March 6, 2019
In a March 6 press release , the Centers for Medicare & Medicaid Services (CMS) announced that the agency's issuance of a request for information (RFI) soliciting recommendations on "how to eliminate regulatory, operational and financial barriers to enhance issuers’ ability to sell health insurance coverage across state lines."
The press release states that the RFI builds on President Trump’s October 12, 2017, Executive Order, “Promoting Healthcare Choice and Competition Across the United States” instructs the administration to facilitate the purchase of health insurance coverage across state lines.
The RFI will be open for public comment for 60 days. View the RFI here .
Posted 3/6/2019
February 28, 2019
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.
February 25, 2019
On February 25, the U.S. Food and Drug Administration approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) for the treatment of adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. Read the Taiho Oncology press release here .
Posted 2/25/2019