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Oncology Newsfeed

  • 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

    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


  • 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



  • FDA Issues EUA for Bamlanivimab and Etesevimab for COVID-19 Treatment

    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



  • FDA Approves Cemiplimab-rwlc as First Immunotherapy for Advanced BCC

    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



  • FDA Approves Lisocabtagene Maraleucel for R/R Large B-Cell Lymphoma

    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