Kristi Rosa

The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

With the breakthrough device designation granted in 2019, the Signatera MRD test now has 3 designations for use across several cancer types and indications.

The FDA has granted a fast track designation to poziotinib for use in previously treated non-small cell lung cancer patients with HER2 exon 20 mutations.

The VENTANA ALK CDx assay is a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer who are eligible to receive treatment with lorlatinib.

The FDA has approved axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

The FDA has approved a supplemental new drug application for lorlatinib (Lorbrena) to expand the indication to include the frontline treatment of patients with ALK-positive non–small cell lung cancer.

A supplemental new drug application has been submitted to the FDA for ivosidenib tablets (Tibsovo) as a potential therapeutic option for patients with previously treated, IDH1-mutated cholangiocarcinoma.

The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma.

The FDA has approved the PD-L1 IHC 22C3 pharmDx assay, developed by Agilent Technologies Inc, for expanded use in patients with non–small cell lung cancer.

The FDA has granted a fast track designation to the DNA-mediated interleukin-12 immunotherapy GEN-1 for use in the treatment of patients with advanced ovarian cancer.

Two supplemental BLAs have been submitted to the FDA for enfortumab vedotin-ejfv to convert its accelerated approval into a regular one and to expand the current label to include patients with locally advanced or metastatic urothelial cancer.

The FDA granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

The FDA has granted priority review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, after at least 1 previous systemic therapy.

The FDA has approved trilaciclib (Cosela) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.

A biologics license application has been submitted to the FDA for the accelerated approval of tisotumab vedotin for use in patients with recurrent or metastatic cervical cancer that has progressed on or following chemotherapy.

The FDA has granted an accelerated approval to umbralisib for the treatment of select patients with relapsed/refractory marginal zone lymphoma and relapsed/refractory follicular lymphoma.

If approved, the biosimilar will be indicated for use in metastatic colorectal cancer, nonsquamous non–small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and metastatic cervical cancer.

The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in patients with soft tissue sarcoma.

The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma.

FDA grant priority review to a supplemental biologics license application for nivolumab (Opdivo) for use as an adjuvant treatment for patients with resected esophageal or gastroesophageal junction cancer.

Narsoplimab is an investigational, fully human IgG4 monoclonal antibody was designed to bind to mannan-binding lectin-associated serine protease-2

A minimally invasive, targeted treatment option, ImPACT is also under evaluation in patients with other localized tumors, such as urothelial cancer, esophageal cancer, lung cancer, and pancreatic cancer.

The FDA has granted an orphan drug designation to the BCMA-targeted trispecific T-cell activating recombinant protein construct as treatment for patients with multiple myeloma.

The FDA has granted fast track designations to cavrotolimod (AST-008) for use in combination with a PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma.

Darolutamide led to a 31% reduction in the risk of death, extending survival for patients with non-metastatic prostate cancer.

FDA approves request submitted by Moleculin Biotech, Inc. for rare disease designations to be granted their drug candidate that appears to directly elicit tumor cell death and prompt the immune system to eliminate tumors.

The FDA has granted a breakthrough therapy designation to tiragolumab for use in combination with atezolizumab (Tecentriq) in the frontline treatment of patients with metastatic non­–small cell lung cancer.

The FDA has granted a fast track designation to an investigational antibody-drug conjugate for use as a monotherapy in the treatment of patients with advanced or metastatic HER2-positive breast cancer.

The biologics license application lisocabtagene maraleucel in adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies continues to be under regulatory review by the FDA.

FDA approves margetuximab-cmkb (Margenza) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens.