Daily Archives: February 5, 2023
Sacituzumab govitecan-hziy is approved by FDA for HR-positive breast cancer
February 5th, 2023 Breast CancerFeb 2023: For patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic t.... Read More
Elacestrant is approved by FDA for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
February 5th, 2023 Breast CancerFeb 2023: Elacestrant (Orserdu, Stemline Therapeutics, Inc.) has been approved by the Food and Drug Administration (FDA) for postmenopausal women or adult men with advanced or metastatic breast cancer who are ER-positive, HER2-negative, and hav.... Read More
Accelerated approval is granted by FDA to pirtobrutinib for relapsed or refractory mantle cell lymphoma
February 5th, 2023 LymphomaFeb 2023: Accelerated approval is granted by FDA to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma. In BRUIN (NCT03740529), an open-label, multicenter, single-arm trial of pirtobrutinib monother.... Read More
Pembrolizumab is approved by FDA as adjuvant treatment for non-small cell lung cancer
February 5th, 2023 Lung cancerFeb 2023: For stage IB (T2a 4 cm), stage II, or stage IIIA non-small cell lung cancer, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) as adjuvant therapy after resection and platinum-based chemotherapy (NSCLC). .... Read More
Zanubrutinib is approved by FDA for chronic lymphocytic leukemia or small lymphocytic lymphoma
February 5th, 2023 LymphomaFeb 2023: Zanubrutinib (Brukinsa, BeiGene USA, Inc.) is approved by FDA for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). SEQUOIA was used to assess effectiveness in CLL/SLL patients who had not received treatment (.... Read More
Accelerated approval is granted by FDA to tucatinib with trastuzumab for colorectal cancer
February 5th, 2023 Colon cancer, Rectal cancerFeb 2023: Tucatinib (Tukysa, Seagen Inc.) and trastuzumab received accelerated approval from the Food and Drug Administration (FDA) for the treatment of RAS wild-type HER2-positive metastatic or unresectable colorectal cancer that has progresse.... Read More