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[9-13-2019] The U.S. Food and Drug Administration (FDA) is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed.
CDK 4/6 inhibitors are a class of prescription medicines that are used in combination with hormone therapies to treat adults with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer that has spread to other parts of the body. CDK 4/6 inhibitors block certain molecules involved in promoting the growth of cancer cells. FDA approved Ibrance in 2015, and both Kisqali and Verzenio in 2017. CDK 4/6 inhibitors have been shown to improve the amount of time after the start of treatment the cancer does not grow substantially and the patient is alive, called progression-free survival. Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe ILD and/or pneumonitis. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-severe-lung-inflammation-ibrance-kisqali-and-verzenio-breast-cancer
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There are two drugs approved by the FDA for the treatment of cancers that have NTRK gene fusions.
On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. On August 15, 2019, the Food and Drug Administration granted accelerated approval to entrectinib for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. The National Pathology Quality Registry (NPQR) is a national quality and benchmarking program led by ASCP. The registry captures data that measure adherence to clinical practice guideline recommendations, quality and performance standards, and appropriate utilization of laboratory testing. NPQR has been granted Qualified Clinical Data Registry (QCDR) status for 2019 by the Centers for Medicare and Medicaid Services (CMS), meaning pathologists and laboratories can harness their laboratory data to both improve patient care and fulfill 2019 MIPS requirements.
NPQR helps laboratories optimize quality and performance and fulfill requirements in several key ways.
The following Hematology/Oncology (Cancer) approvals were posted on the FDA website in May 2019:
FDA approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. More Information. May 29, 2019 FDA approved lenalidomide (REVLIMID, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). More Information. May 28, 2019 FDA approved alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. More Information. May 24, 2019 FDA approved ruxolitinib (JAKAFI, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. More Information. May 24, 2019 FDA approved dalteparin sodium (FRAGMIN, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. More Information. May 16, 2019 FDA approved approved venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)..More Information. May 15, 2019 FDA approved avelumab (BAVENCIO, EMD Serono, Inc.) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). More Information. May 14, 2019 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. More Information. May 10, 2019 FDA approved ado-trastuzumab emtansine (KADCYLA, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. More Information. May 3, 2019 FDA approved ivosidenib (TIBSOVO, Agios Pharmaceuticals, Inc.) for 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. More Information. May 2, 2019 Don't miss this free CME activity titled:
Overcoming Common Barriers Around the Application of Immuno-Oncology in Community Settings This CME multidisciplinary panel discussion will feature interactive problem-based learning with a focus on common barriers to implementing and delivering IO in community pathology settings, including a practical discussion around overcoming some of those barriers. Some areas identified as needing pathology leadership and support are evidence-based QI planning for disease-specific IO procedures and developing consistent protocols and workflows related to cancer diagnosis and the use of IO treatments. This is a unique year-long part-time opportunity to conduct important research at the National Cancer Institute (NCI) in Rockville, Maryland.
The NCI/AcademyHealth Healthcare Delivery Research Visiting Scholars Program was launched in 2017 by the Healthcare Delivery Research Program of NCI in partnership with AcademyHealth to address key gaps and advance the field of cancer care delivery research. This unique program offers mid-career scientists a year-long, funded part-time opportunity to contribute evidence and address cancer care challenges by conducting research and pursuing projects at the National Cancer Institute (NCI) in Rockville, MD. The program provides individuals with protected time to develop new research directions that advance both their own career goals and the field. Why Become a Scholar?
Learn more about the program here: https://www.academyhealth.org/NCI/ScholarProgram The Visiting Scholar(s) is housed in NCI’s Healthcare Delivery Research Program (HDRP). HDRP’s mission is to advance innovative research to improve the delivery of cancer-related care and it accomplishes this work through its three Branches: Healthcare Assessment Research Branch, Health Systems and Interventions Research Branch, and Outcomes Research Branch. This free CME activity is available from ASCP.org
Implementing Immuno-Oncology Education in a Community Cancer Center This CME panel discussion features faculty and members of the inter-professional team involved in an Implementation Science (IS) pilot program at a community cancer center. Panelists will discuss key findings related to the challenges and barriers they had to overcome in implementing immuno-oncology education, lessons learned, and plans for sustaining changes and improvements. FDA approved cabozantinib (CABOMETYX, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. More Information, January 14, 2019
Evolving terminology regarding cancer immunotherapy side effects (immune-mediated adverse reactions)1/8/2019
What terms should we be using for treatment-related side effects that are associated with various cancer immune checkpoint inhibitor therapy? The NCCN guidelines (developed in partnership with ASCO) are titled, "Management of Immunotherapy-Related Toxicities." ASCO named their guideline, "Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy." Over the past few years, many published studies used the term "immune-related adverse events or irAEs." The SITC toxicity management working group published consensus recommendations using the phrase "immune-related adverse events." In press releases and news updates, the FDA used phrases like "Infection and immune-related adverse events such as pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency, diabetes, pancreatitis, and dermatitis/rash were also seen with ..." (At times, the FDA used the term "immune-mediated adverse reactions") We may be entering an era where the phrase "irAE" may be going away. It may get replaced with "imAE." As of Jan 2019, here is what you will find on the websites of PD-1 and PD-L1 inhibitors:
You can find more information about specific immune-mediated adverse reactions such as immune-mediated pneumonitis; immune-mediated hepatitis; immune-mediated colitis; and others. What is the distinction between immune-related vs. immune-mediated? Let's start by reviewing some definitions:
The link between immune activation and immune-mediated adverse reactions is an active area of ongoing research. PD-1 and PD-L1 inhibitors approved by the FDA (as of Jan 2019) include:
ASCP’s Innovative Immuno-Oncology Education for Pathologists and Laboratory Professionals12/28/2018
Breakthroughs in immuno-oncology (IO) are showing great potential to revolutionize cancer treatment, but keeping up-to-date with new testing protocols, diagnoses, and therapeutic treatments is challenging for many pathologists and laboratory professionals.
Given the rapidly evolving nature of the IO field, the American Society for Clinical Pathology (ASCP) IO Work Group set out to create a comprehensive educational strategy to guide the development of education designed to enhance the knowledge and skills that today’s pathologists and laboratory professionals need to stay at the top of their career. Learn more the work that ASCP is doing to provide Immuno-Oncology continuing education. Visit: https://www.ascp.org/content/learning/immuno-oncology |