Kristi Rosa

The FDA has granted a fast track designation to IO-202, a first-in-class anti-LILRB4 myeloid checkpoint inhibitor, as a potential therapeutic option for patients with relapsed or refractory acute myeloid leukemia.

The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of the CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma in whom frontline therapy has failed.

The FDA has placed a clinical hold on a phase 1 trial evaluating the safety and efficacy of the autologous CAR T-cell product LB1901 as a potential therapeutic option in adult patients with relapsed or refractory T-cell lymphoma.

The FDA has accepted a new drug application for the use of adagrasib in the treatment of patients with non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have previously received at least 1 prior systemic therapy.

The FDA has granted a breakthrough device designation to the TriNetra-Prostate blood test for use in the detection of early-stage prostate cancer.

The FDA has accepted for review a new drug application for poziotinib in patients with previously treated locally advanced or metastatic non–small cell lung cancer with HER2 exon 20 insertion mutations.

The novel non-viral gene therapy, EG-70, produced a complete response rate of 83% at 3 months in evaluable patients with high-grade non–muscle invasive bladder cancer with carcinoma in situ who were unresponsive to Bacillus Calmette-Guérin.

Induction treatment with ibrutinib and rituximab was safe and active in patients with mantle cell lymphoma aged 65 years or younger, allowing for fewer cycles of subsequent chemotherapy with rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone thereby reducing toxicity.

With 9 approved markers in non–small cell lung cancer and a plethora of established and emerging therapies that have been designed to target them, the need for molecular testing is more important than ever.

Lyudmila Bazhenova, MD, explores key challenges faced with diagnosing and appropriately treating patients with non–small cell lung cancer that harbors EGFR exon 20 insertion mutations and provides insight into the second-line options that have recently garnered regulatory approval.

Frontline maintenance treatment with selinexor resulted in a statistically significant improvement in median progression-free survival vs placebo in patients with advanced or recurrent endometrial cancer, meeting the primary end point of the phase 3 SIENDO trial.

Antibody-drug conjugates appear to have the most activity in those with non–small cell lung cancer and HER2 expression.

The FDA has announced that they are investigating umbralisib (Ukoniq), an oral inhibitor of PI3K-delta and CK1-epsilon that is approved to treat patients with marginal zone lymphoma and follicular lymphoma, after initial data from the phase 3 UNITY-CLL trial revealed a potential increased risk of death in those who received the agent.

The 3-patient safety run-in for the pancreatic cancer cohort of the ongoing phase 1/2 GOBLET study did not reveal any safety concerns with the novel combination of pelareorep and atezolizumab.

The combination of brentuximab vedotin and chemotherapy resulted in a statistically significant improvement in overall survival when used in the frontline treatment of patients with advanced classical Hodgkin lymphoma.

The submission of a supplemental biologics license application seeking the approval of a Monday/Wednesday/Friday intramuscular dosing schedule for asparaginase erwinia chrysanthemi-rywn for use as a component of a multiagent chemotherapy regimen in patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity to Escherichia coli–derived asparaginase has been submitted to the FDA.

The FDA has granted a rare pediatric disease designation to the bone-targeting radiopharmaceutical, Samarium-153-DOTMP, for use as a potential therapeutic option for patients with osteosarcoma.

Significant progress has been made toward the initiation of the phase 3 FLAMINGO-01 trial, which will evaluate the combination of the immunotherapy GP2 with granulocyte macrophage colony stimulating factor in the adjuvant treatment of HER2/neu- and HLA-A*02–positive patients following surgery and trastuzumab-based therapy.

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment option for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended to expand the current indication for avapritinib to include single-agent use in patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, or mast cell leukemia.

The FDA has approved an update to the prescribing information for axicabtagene ciloleucel to include use of prophylactic corticosteroids across all approved indications.

Regeneron Pharmaceuticals, Inc. and Sanofi announced the voluntarily withdrawal of the supplemental biologics license application for cemiplimab-rwlc as a second-line treatment for patients with advanced cervical cancer whose disease progressed on or after chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B following 2 or more lines of systemic therapy.

The European Commission has granted a marketing authorization for lorlatinib for use as a single agent in the treatment of adult patients with ALK-positive advanced non–small cell lung cancer who did not receive a prior ALK inhibitor.

The FDA has placed a partial clinical hold on clinical trials evaluating the combination of magrolimab and azacitidine after an apparent imbalance in investigator-reported, suspected unexpected serious adverse reactions observed between study arms.

The global biopharmaceutical company Incyte has decided to withdraw the new drug application for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.

The FDA has approved tebentafusp-tebn for the treatment of HLA-A*02:01–positive adult patients with unresectable or metastatic uveal melanoma.

The FDA has granted a fast track designation to CX-5461 (Pidnarulex) as a potential therapeutic option for patients with breast and ovarian cancers that harbor BRCA1/2, PALB2, or other homologous recombination deficiency mutations.

The PD-L1 antibody cosibelimab, when given at a fixed dose of 800 mg every 2 weeks, elicited a promising objective response rate with acceptable safety and tolerability in patients with metastatic cutaneous squamous cell carcinoma, meeting the primary end point of a phase 1 registration-enabling trial.