On August 5, 2022, the U.S Food and Drug Administration (FDA) approved fam-trastuzumab-deruxtecan-nxki, an IV infusion, for the treatment of patients with unresectable or metastatic HER2-low breast cancer. This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.
For more information, read the FDA announcement .
Posted on 8/5/2022
On August 5, 2022, the Food and Drug Administration approved new tablet formulation of acalabrutinib (Calquence, AstraZeneca) under accelerated approval based on overall response rate for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and patients with relapsed or refractory mantle cell lymphoma.
Read full press release.
Posted on 08/05/2022
On June 9, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne®CDx as a companion diagnostic for two entrectinib indications:
To identify patients with ROS1-positive non-small cell lung cancer
To identify patients with neurotrophic tyrosine receptor kinase fusion-positive solid tumors.
Both indications are for patients who may be appropriate for treatment with entrectinib.
For more information, read Foundation Medicine's announcement and Roche's announcement.
On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved both nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of programmed death-ligand 1 (PD-L1) status.
For more information, read Bristol Myers Squibb's announcement.
On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.
For more information, read Novartis' announcement.
Fam-Trastuzumab Deruxtecan-Nxki (Enhertu®, Daiichi Sankyo, AstraZeneca) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Read press release.