Gina Columbus

The FDA has approved atezolizumab (Tecentriq) in combination with carboplatin and nab-paclitaxel (Abraxane) for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) who do not harbor EGFR or ALK molecular aberrations.

The FDA has granted a priority review designation to pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.

The FDA has granted a priority review to the agent pemigatinib for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

Two new single agents led to brain penetrance and 2-hydroxyglutarate (2-HG) suppression in patients with low-grade glioma who harbor IDH1 mutations, according to updated findings.

In a phase III trial of nivolumab/ipilimumab to treat patients with melanoma in the adjuvant setting results showed the drugs missed their coprimary end point.

The FDA accepts the application of a biosimilar of bevacizumab in the treatment of patients with NSCLC.

The FDA has granted a priority review to the combination treatment of nivolumab and ipilimumab to treat patients with advanced HCC.

The therapy is now approved for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

The FDA has approved the biosimilar pegfilgrastim for treatment to decrease the incidence of infection exhibited from febrile neutropenia.

The FDA has granted an RMAT designation for an investigational CAR-T cell therapy used to treat patients with multiple myeloma.

The NDA for Blueprint Medicines' agent avapritinib will be split into two separate submissions for patients with GIST.

An update to the biologics license application of eflapegrastim has been resubmitted to the FDA to include chemo-induced neutropenia.

The FDA approves the use of niraparib in the treatment of patients with HRD-positive advanced ovarian cancer based on results from the phase II QUADRA study.

The FDA has expanded the approval of aprepitant to include in its label the use of a single dose regimen in patients receiving moderately epigenetic chemotherapy.

Earlier today, the FDA approved daratumumab, in combination with other treatments, to treat patients with multiple myeloma that are eligible for autologous stem cell transplant.

Popular noninvasive colorectal cancer screening test, Cologuard, recently received permission from the FDA to expand its test.

The FDA has granted accelerated approval to the combination of lenvatinib and pembrolizumab in the treatment of patients with advanced endometrial carcinoma.

In about 3% to 5% of patients with NSCLC MET alterations are presented that can drastically change a patient's prognosis. Now, an investigational MET inhibitor called tepotinib was granted a breakthrough designation by the FDA, and it may prove beneficial for patients in this space.

Patients with METex14-Mutated NSCLC potentially have a new first-line treatment to look towards as Capmatinib has been granted a breakthrough designation by the FDA.

The FDA has approved darolutamide (Nubeqa) for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

One expert discusses the arrival of immunotherapy, as well as other exciting advances, for the treatment of patients with small cell lung cancer.

The FDA has granted a priority review designation to a supplemental biologics license application for niraparib (Zejula) for the treatment of patients with advanced ovarian cancer.

The FDA has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM), marking the first treatment for this patient population in more than 15 years.

Nivolumab plus radiation did not improve overall survival compared to temololomide in patients with newly diagnosed glioblastoma.

The Food and Drug Administration granted leronlimab a fast track designation for the treatment of patients with metastatic triple-negative breast cancer.

The FDA has approved a supplemental new drug application (sNDA) for ivosidenib (Tibsovo) as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia (AML), as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.

The FDA has granted a priority review designation to a new drug application (NDA) for darolutamide for use as a treatment for patients with nonmetastatic castration-resistant prostate cancer (CRPC).

The FDA has approved pembrolizumab (Keytruda) in combination with axitinib (Inlyta) for the frontline treatment of patients with advanced renal cell carcinoma (RCC).