FDA grants clearance for radiation oncology tool to calculate absorbed dose of radionuclides

FDA approves inavolisib + palbociclib + fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

FDA approved Itovebi (inavolisib) with palbociclib (Ibrance) and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth-factor receptor 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

October 11, 2024

Vol.50 No.38

Drugs & Targets

FDA clears the way for multi-center investigator-initiated study of Alpha DaRT in immunocompromised patients with recurrent cSCC

FDA approved an Investigational Device Exemption application to initiate a multi-center study for the treatment of recurrent cutaneous squamous cell carcinoma in immunocompromised patients using the Alpha DaRT.

October 11, 2024

Vol.50 No.38

Drugs & Targets

FDA approves neoadjuvant/adjuvant Opdivo for resectable NSCLC

FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent Opdivo after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

October 04, 2024

Vol.50 No.37

Drugs & Targets

FDA approves Retevmo for medullary thyroid cancer with RET mutation

FDA granted traditional approval to Retevmo (selpercatinib) for adult and pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.

October 04, 2024

Vol.50 No.37

Drugs & Targets

FDA approves Cologuard Plus Test for non-invasive CRC screening

FDA approved the Cologuard Plus test, a multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer.

October 04, 2024

Vol.50 No.37