April 8, 2021
On April 7, 2021 the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan-hziy for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Read the FDA announcement .
Read the Gilead Sciences announcement .
Posted 4/8/2021
April 7, 2021
On March 30, 2021, the Academy of Oncology Nurse & Patient Navigators (AONN+) Leadership Council released key reasons why cancer care teams should be protected and thoughtful investment strategies for cancer programs and practices to help remain strong as they recover from the pandemic. After closely reviewing the pandemic's impact on cancer care delivery in 2020, the Leadership Council devised key reasoning for protecting the cancer care team and service line:
"With new testing and mitigation strategies being implemented and improved access to vaccines on the horizon, now is the time to proactively plan for the near future. With proper and realistic planning, members of the cancer care team can be well-positioned to serve their patients with cancer and their families as the pandemic begins to subside."
The AONN+ Leadership Council is led by Christian Downs, executive director of the Association of Cancer Care Centers, with support from Linda Fleisher, principal investigator at Fox Chase Cancer Center, Lillie Shockney, co-founder of AONN+, Rani Khetarpal, vice president of Provider Partnerships at New Century Health, and Mandi Pratt-Chapman, associate center director of Patient-Centered Initiatives and Health Equity at George Washington Cancer Center.
For more information on the Leadership Councils' tips for a strong cancer care team post-pandemic, read the full announcement .
Posted 4/7/2021
April 6, 2021
On October 13, 2020, the U.S. Food and Drug Administration (FDA) granted miR Scientific's miR Sentinel™ PCC4 Assay (miR Sentinel™ Prostate Test) breakthrough device designation. The miR Sentinel™ Prostate Test is a new method to analyze small non-coding RNAs from a non-invasive urine specimen from age-eligible men.
Read the company's announcement .
Posted 4/6/2021
April 5, 2021
The Centers for Medicare & Medicaid Services (CMS) has released six new billing codes for oncology-related products. These codes start April 1, 2021. The products, their associated codes, billing units, and Medicare payment limits are:
Posted 4/5/2021
April 1, 2021
On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received one to three prior lines of therapy.
Read the FDA announcement .
Read the Sanofi announcement .
Posted 4/1/2021
April 1, 2021
On March 31, 2021 Eisai Inc. and advocacy leaders announced that they have teamed up to launch Spot Her , an initiative to end the silence around endometrial cancer and inspire women to listen, advocate, and put their health and the health of other women first, including helping women spot the signs of early endometrial cancer.The Spot Her initiative aims to embrace the power of every woman’s voice to take a stand on this important women’s health issue by providing support through education, resources, and strength through community.
For more information on this initiative, visit Spot Her .
Posted 4/1/2021
March 31, 2021
On March 30, 2021, the U.S. Food and Drug Administration approved the revised label for daunorubicin and cytarabine to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes in pediatric patients aged one year and older.
Read the Jazz Pharmaceuticals announcement .
Posted 3/31/2021
March 29, 2021
On March 26, 2021, the U.S. Food and Drug Administration approved idecabtagene vicleucel as the first B-cell maturation antigen directed chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Read the FDA announcement .
Read the Bristol Myers Squibb announcement .
Read the bluebird bio, Inc. announcement .
Posted 3/29/21
March 24, 2021
On March 23, 2021, Bayer announced that it is collaborating with NeoGenomics, Tempus, and Veracyte to sponsor genomic cancer testing for actionable alterations, including NTRK gene fusions. These programs are available to eligible patients at no cost. Bayer will cover the full cost of the test regardless of the results, patient’s insurance coverage, and resulting treatment decision.
Eligibility includes patients with RAI-refractory differentiated thyroid carcinoma and metastatic colorectal cancer with high microsatellite instability.
Enrollment for the the programs is available for a limited time, and these genomic testing programs include:
Visit each program's website for more information.
Posted 3/24/2021
March 23, 2021
On March 22, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation.
Read the FDA announcement .
Read Merck's announcement .
Posted 3/23/2021
March 19, 2021
On March 18, 2021, Boston Scientific Corporation announced it received approval from the U.S. Food and Drug Administration (FDA) for the TheraSphere™ Y-90 Glass Microspheres for the treatment of patients with hepatocellular carcinoma (HCC). TheraSphere is the only radioembolization technology indicated for the treatment of unresectable HCC in the United States.
Read Boston Scientific Corporation's announcement .
Posted 3/19/2021
March 11, 2021
On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved tivozanib for adult patients with relapsed or refractory (R/R) advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
Read the FDA announcement .
Read AVEO Oncology's announcement .
Posted 3/11/2021
March 9, 2021
On March 9, 2021, the U.S. Preventative Services Task Force (USPSTF) announced it has updated its lung cancer screening recommendations. The task force now recommends annual screening for lung cancer with low-dose computed tomography in adults aged 50 to 80 years (previously 55 to 80 years) who have a 20 pack-years smoking history (previously 30 pack-years) or who have quit within the last 15 years. This update nearly doubles the number of people eligible for screening.
The update also has a direct impact on addressing disparities associated with lung cancer. The expansion of the eligible patient criteria will allow more patients of ethnic and racial minorities and women to qualify for lung cancer screening.
The USPSTF is an independent, volunteer panel of national experts in disease prevention and evidence-based medicine.
Read the updated USPTSF recommendations .
Posted 3/9/2021
March 8, 2021
On March 5, 2021, the U.S. Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.
Read the FDA announcement . Read Kite's announcement .
Posted 3/8/21
March 4, 2021
On March 3, 2021, the U.S. Food and Drug Administration (FDA) expanded lorlatinib's indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorlatinib is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.
Read Pfizer's announcement .
Posted 3/4/21
March 1, 2021
On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The Janssen COVID-19 Vaccine is administered as a single dose.
Read the full FDA information on the Janssen COVID-19 Vaccine .
Posted 3/1/21
March 1, 2021
On February 26, 2020 the U.S. Food and Drug Administration (FDA) approved melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM), who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Read Oncopeptides' announcement .
Posted 3/1/21
February 23, 2021
On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved the PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying patients with NSCLC with tumor PD-L1 expression of Tumor Proportion Score greater than or equal to 50 percent for treatment with Libtayo® (cemiplimab-rwlc).
Read Agilent Technologies Inc. announcement .
February 22, 2021
On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc for the first-line treatment of advanced non-small cell lung cancer (NSCLC) in patients whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations.
Read the FDA announcement .
Read the Sanofi announcement.
Posted 2/22/2021
February 16, 2021
On February 16, 2021, G1 Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved "trilaciclib for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy."
Read the full company announcement .
Read the FDA announcement .
Posted 2/16/2021
February 11, 2021
On February 11, 2021, InsideHealthPolicy announced that hospitals across the United States have asked the Supreme Court "to take up their lawsuits against the Trump administration’s Medicare Part B reimbursement cuts for 340B drugs and pay cuts for outpatient clinic visits at certain off-campus hospital facilities, alleging the U.S. Court of Appeals for the District of Columbia Circuit gave too much weight to the U.S. Department of Health and Human Services' interpretation of the statute in each situation."
Read more on this at InsideHealthPolicy .
Posted 2/11/2021
February 10, 2021
On February 9, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.
The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.
Read the FDA announcement .
Posted 2/10/21
February 10, 2021
On February 9, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to cemiplimab-rwlc for patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic basal cell carxinoma previously treated with a HHI or for whom a HHI is not appropriate.
Read the FDA announcement .
Read Sanofi and Regeneron's announcements.
Posted 2/10/21
February 8, 2021
On February 5, 2021, the U.S. Food and Drug Administration (FDA)Â approved lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Read the FDA announcement .
Read the Bristol Myers Squibb announcement .
Posted 2/8/2021