Oncology Newsfeed

FDA Approves Tivozanib for R/R Advanced RCC

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

The USPSTF Announces Update to Lung Cancer Screening Recommendations

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

The FDA Approves Axicabtagene Ciloleucel for R/R Follicular Lymphoma

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

FDA Expands Lorlatinib Approval to Include ALK-Positive NSCLC

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

FDA Issues EUA for Third COVID-19 Vaccine

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

FDA Approves Melphalan Flufenamide for R/R MM

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

FDA Approves the PD-L1 IHC 22C3 pharmDx Assay for NSCLC

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.

FDA Approves Cemiplimab-rwlc Monotherapy for Advanced NSCLC

FDA Approves Trilaciclib for Chemotherapy-Induced Myelosuppression in ES-SCLC

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

U.S. Hospitals Request the Reversals of the 340B-Drug and Pay Cuts Rulings

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