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) 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
February 8, 2021
On February 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to umbralisib for the following indications:
Read the FDA announcement .
Read TG Therapeutics' announcement .
Posted 2/8/2021
February 4, 2021
On February 3, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib for adult patients with metastatic non-small cell lung cancer (NSCLC) barboring mesenchymal-epithelial transition exon 14 skipping alterations.
This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Read the FDA announcement .
Read Merck KGaA's announcement .
Posted 2/4/21
January 22, 2021
On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).
Read Bristol Myers Squibb's announcement .
Read the FDA announcement .
Posted 1/22/2021
January 22, 2021
On January 22, 2021, the National Comprehensive Cancer Network (NCCN) released new information providing guidance to cancer care providers for vaccinating people with cancer against COVID-19. The NCCN COVID-19 Vaccine Committee recommends that all people currently in active cancer treatment be vaccinated, with considerations regarding immunosuppression and timing. The committee will also meet regularly to update the released recommendations and new recommendations, as they arise.
Read the full NCCN: Cancer and COVID-19 Vaccination recommendations and find more NCCN resources on its COVID-19 Resources web page .
Posted 1/21/2021
January 19, 2021
On January 15, 2021, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.
Read the FDA announcement .
Read Daiichi Sankyo's announcement .
Posted 1/19/2021
January 5, 2021
The Centers for Medicare and Medicaid Services (CMS) released the C-code C9369 (injection, belantamab mafodontin-blmf, 0.5 mg) for GlaxoSmitheKline's Blenrep (belantamab mafodotin-blmf), effective January 1, 2021.
Posted 1/5/2021
December 21, 2020
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.
Read the FDA announcement .
Read AstraZeneca's announcement .
Posted 12/21/2020
December 21, 2020
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved relugolix for the treatment of adult patients with advanced prostate cancer. It is the first and only oral gonadotropin-releasing hormone receptor antagonist for men with advanced prostate cancer.
Read the FDA announcement .
Read Myovant Sciences' announcement .
Posted 12/21/2020
December 21, 2020
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior
therapy. Selinexor was previously approved under the FDA's accelerated approval program for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Read the FDA announcement .
Read Karyopharm Therapeutics' announcement .
Posted 12/21/2020
December 19, 2020
On December 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. The FDA has determined that the vaccine has met the statutory criteria for issuance of an EUA.
Read the FDA announcement .
Posted 12/18/2020
December 18, 2020
On December 17, 2020, the U.S. Food and Drug Administration (FDA) approved Amgen's rituximab biosimilar Riabni™ (rituximab-arrx), which references Rituxan® (rituximab) and is indicated for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
Read Amgen's announcement .
Posted 12/18/2020
December 17, 2020
On December 16, 2020, the U.S. Food and Drug Administration (FDA) approved margetuximab-cmkb in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
Read the FDA announcement .
Read MacroGenics' announcement .
Posted 12/17/2020