Approval Alert brings together the most up-to-date information on the latest FDA approvals. Clinical trial investigators and thought leaders provide their perspective on newly approved agents and how they stand to change the treatment paradigm.
In November 2023, the FDA approved nirogacestat as a treatment for patients with progressing desmoid tumors that require systemic therapeutics.
In November 2023, the FDA approved capivasertib plus fulvestrant for patients with locally advanced or metastatic breast cancer that is hormone receptor–positive, HER2-negative with 1 or more PIK3CA, AKT1, or PTEN alterations, and has progressed on or after 1 endocrine-based regimen in the metastatic setting, or recurrence on or within 12 months of completing adjuvant treatment.
In November 2023, the FDA approved fruquintinib for patients with previously treated metastatic colorectal cancer based on results from the phase 3 FRESCO-2 trial.
In August 2023, the FDA approved luspatercept-aamt for patients with lower-risk myelodysplastic syndrome (MDS) with anemia in the first line
In July 2023, the FDA approved dostarlimab plus chemotherapy as a frontline treatment option for patients with primary advanced or recurrent mismatch repair deficient or microsatellite instability–high endometrial cancer.
In May 2023, the FDA approved olaparib plus abiraterone and prednisone or prednisolone for patients with BRCA-mutated metastatic castration-resistant prostate cancer as determined by an FDA-approved test.
In April 2023, the FDA approved polatuzumab vedotin-piiq in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone as a treatment for patients with previously untreated diffuse large B-cell lymphoma.
In April 2023, the FDA approved enfortumab vedotin-ejfv plus pembrolizumab as a combination therapy for patients with locally advanced or metastatic urothelial cancer who cannot receive cisplatin-based chemotherapy.
In February 2023, the FDA approved sacituzumab govitecan-hziy for the treatment of patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer in patients who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
In January 2023, the FDA approved elacestrant for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with progression after at least 1 line of therapy.
In January 2023, the FDA gave accelerated approval to pirtobrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma following at least 2 prior lines of therapy.
In January 2023, the FDA approved adjuvant pembrolizumab for the treatment of completely resected non-small cell lung cancer.
In January 2023, the FDA has given tucatinib in combination with trastuzumab accelerated approval by the FDA for the treatment of patients with RAS wild-type, HER2-positive metastatic colorectal cancer who have received at least 1 line of treatment for unresectable or metastatic disease.
In December 2022, the FDA has approved mosunetuzumab-axgb for patients with relapsed/refractory follicular lymphoma after 2 prior lines of therapy.
In December 2022, adagrasib was granted accelerated approval by the FDA for patients with KRAS G12C–mutated non–small cell lung cancer, as determined by an FDA-approved test.
In November 2022, the FDA approved tremelimumab plus durvalumab and platinum-based chemotherapy for patients with metastatic non–small cell lung cancer who have an EGFR mutation or ALK alteration.
In November 2022, mirvetuximab soravtansine-gynx was given accelerated approval by the FDA for the treatment of patients with folate receptor-α-positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer cancer who have been treated with 1 to 3 lines of prior therapy.
In October 2022, the FDA approved tremelimumab and durvalumab for patients with unresectable hepatocellular carcinoma.
In October 22, the FDA granted accelerated approval to teclistamab-cqvy for patients with relapsed/refractory multiple myeloma.
In August 2022, the FDA granted approval to oral darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.
In August 2022, the FDA approved betibeglogene autotemcel for adult and pediatric patients with β-thalassemia who need regular red blood cell infusions.
In June 2022, the FDA approved lisocabtagene maraleucel as treatment for relapsed/refractory large B-cell lymphoma following 1 prior line of therapy.
In May 2022, nivolumab plus chemotherapy and nivolumab plus ipilimumab was approved by the FDA as a treatment for patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression.
In May 2022, the FDA approved the use of fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti-HER2 treatment in the metastatic, neoadjuvant, or adjuvant setting followed by disease recurrence during treatment or within 6 months of completing therapy.
In March 2022, the FDA approved pembrolizumab for advanced microsatellite instability–high or mismatch repair–deficient advanced endometrial cancer following prior systemic therapy in any setting.
In April 2022, axicabtagene ciloleucel was approved by the FDA for the treatment of adult patients with large B-cell lymphoma whose disease was refractory to or which relapsed within 12 months after first-line chemoimmunotherapy.
In March 2022, the FDA granted approval to the targeted radioligand 177Lu-PSMA-617 for the treatment of patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have previously been treated with an androgen-receptor pathway inhibitor and taxane-based chemotherapy.
In February 2022, the FDA granted accelerated approval to pacritinib for intermediate or high-risk primary or secondary myelofibrosis with severe thrombocytopenia.
In February 2022, the FDA approved ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy.
In November 2021, the FDA approved pafolacianine for use as an imaging drug for identifying lesions in patients with ovarian cancer during surgery.