Kristi Rosa

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adults with unresectable malignant pleural mesothelioma.

The new drug application seeking the approval of a unique formulation of sodium thiosulfate for the prevention of ototoxicity induced by cisplatin chemotherapy in patients aged 1 month to less than 18 years of age with localized, nonmetastatic solid tumors has been resubmitted to the FDA.

The FDA has approved the Guardant360 CDx assay as a companion diagnostic for tumor mutation profiling to identify patients with locally advanced or metastatic non–small cell lung cancer whose tumors harbor the KRAS G12C mutation and may derive benefit from sotorasib.

The FDA has granted a priority review to the new drug application seeking approval of plinabulin plus granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

The FDA has granted priority review to a new drug application for pacritinib as a potential treatment option for patients with myelofibrosis and severe thrombocytopenia, defined as platelet counts less than 50 x 109/L.

The combination of cabozantinib plus atezolizumab was found to elicit encouraging response rates, disease control, and acceptable safety in patients with metastatic castration-resistant prostate cancer who had previously received enzalutamide and/or abiraterone acetate.

The FDA has approved infigratinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

The FDA has approved sotorasib as the first treatment for adult patients with non–small cell lung cancer whose tumors harbor KRAS G12C mutations and who have received at least 1 prior systemic therapy.

The FDA has approved a 6-month subcutaneous depot formulation of leuprolide mesylate as a ready-to-use treatment for patients with advanced prostate cancer.

The FDA has granted priority review to the biologics license application for ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma.

The FDA has approved piflufolastat F 18 injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer.

Melphalan flufenamide has been shown to be noninferior to pomalidomide in the treatment of patients with relapsed/refractory multiple myeloma.

Afamitresgene autoleucel was found be efficacious with favorable tolerability in heavily pretreated patients with advanced synovial sarcoma or myxoid/round cell liposarcoma, according to data from phase 2 SPEARHEAD-1 trial.

The FDA has granted approval to the Guardant360 CDx liquid biopsy assay as the first companion diagnostic for amivantamab-vmjw to determine which patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations may derive benefit from the agent after progressing on, or after, platinum-based chemotherapy.

The European Commission has approved venetoclax for use in combination with azacitidine and decitabine in the treatment of adult patients with newly diagnosed acute myeloid leukemia who are not candidates to receive intensive chemotherapy.

The FDA has granted a breakthrough therapy designation to VS-6766 plus defactinib for the treatment of patients with recurrent low-grade serous ovarian cancer, irrespective of KRAS status, following 1 or more previous lines of therapy, including platinum-based chemotherapy

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab for use in 2 advanced cancers: non–small cell lung cancer and basal cell carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2-negative gastroesophageal junction adenocarcinoma with PD-L1 positivity.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of nivolumab and ipilimumab as an option for patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following fluoropyrimidine-based combination therapy.

A biologics license application has been submitted to the FDA for the PD-1 monoclonal antibody penpulimab for the third-line treatment of patients with metastatic nasopharyngeal carcinoma.

The FDA has announced that it will need more time to review the biologics license application for narsoplimab as a potential therapeutic option in patients with hematopoietic stem cell transplant–associated thrombotic microangiopathy.

The FDA has accepted a new drug application for maribavir for the treatment of post-transplant recipients with cytomegalovirus infection who are refractory and/or resistant to previous anti-CMV treatment.

The FDA has approved amivantamab-vmjw as the first treatment for adult patients with non–small cell lung cancer who harbor EGFR exon 20 insertion mutations.

The combination of the anti–PD-1 tislelizumab and chemotherapy was found to significantly improve progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial.

The FDA has approved nivolumab for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, in patients have received neoadjuvant chemoradiotherapy.

The biologics license application seeking the approval of ropeginterferon alfa-2b-njft for use in the treatment of patients with polycythemia vera has been resubmitted to the FDA.

The FDA has granted a fast track designation to the CAR T-cell product AIC100 for the treatment of patients with anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer.

The FDA has granted priority review to a supplemental new drug application for zanubrutinib as a treatment option for adult patients with marginal zone lymphoma who have previously received at least 1 anti-CD20–based therapy.

Loncastuximab tesirine-lypl has demonstrated significant antitumor activity with durable responses and an acceptable toxicity profile, when used as a monotherapy in heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma.

A biologics license application for sintilimab injection plus pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with nonsquamous non–small cell lung cancer has been accepted for FDA review.