FDA Approvals, News & Updates
Yescarta is the first CAR T-cell therapy approved by the FDA for patients with follicular lymphoma. It uses the patient’s own genetically modified T-cells to fight the cancer. Read More ›
Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA, and is the first targeted, once-daily oral therapy option for marginal-zone or follicular lymphoma. Read More ›
“Today’s approval represents another milestone in the rapidly progressing field of gene therapy,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research. Read More ›
In December 2020, the FDA approved Margenza (margetuximab-cmkb), a new targeted therapy, for the treatment of patients with metastatic HER2-positive breast cancer, representing an important new option for patients with this type of breast cancer that continues to progress despite different treatments. Read More ›
In February 2021, the FDA approved Tepmetko (tepotinib), a new oral targeted therapy, for the treatment of all adults with metastatic non–small-cell lung cancer and MET exon 14 alterations. Tepmetko is the second MET inhibitor that has been approved by the FDA. Read More ›
In December 2020, the FDA approved Tagrisso (osimertinib) for adjuvant therapy (continued therapy to prevent cancer recurrence) after surgical removal of the tumor, in patients with non–small-cell lung cancer and EGFR exon 19 deletions or exon 21 L858R mutations. Tagrisso was previously approved for the treatment of other types of lung cancer. Read More ›
In December 2020, the FDA approved Orgovyx (relugolix), as the first oral hormone therapy for the treatment of men with advanced prostate cancer. This new drug may eliminate the need to visit the clinic for treatment, helping patients with cancer avoid unnecessary exposure during the pandemic. Read More ›
In January 2021, the FDA approved a new indication for Xalkori (crizotinib), an oral ALK inhibitor, for the treatment of young patients who are diagnosed with relapsed or refractory systemic anaplastic large-cell lymphoma and ALK mutation. Xalkori was previously approved for metastatic lung cancer and ALK or ROS1 mutation. Read More ›
In December 2020, the FDA approved Xpovio (selinexor), for use in combination with the proteasome inhibitor Velcade (bortezomib) and the steroid dexamethasone, for the treatment of adults with multiple myeloma who have received at least 1 previous therapy. Xpovio was previously approved for several types of lymphoma. Read More ›