CLINICAL ROLE -
FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
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.
FDA Awards Breakthrough Device Designations to Signatera Molecular Residual Disease Test
With the breakthrough device designation granted in 2019, the Signatera MRD test now has 3 designations for use across several cancer types and indications.
FDA Awards Fast Track Status to Treatment for HER2 Exon 20–Mutated NSCLC
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.
FDA Approves Companion Diagnostic for ALK-Positive Non–Small Cell Lung Cancer Treatment
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.
Axi-Cel Granted Accelerated Approval for Relapsed/Refractory Indolent Follicular Lymphoma
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.
FDA Expands Indication of Lorlatinib for ALK-Positive Non–Small Cell Lung Cancer
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.
NDA Submitted to FDA for Ivosidenib for Previously Treated IDH1-Mutated Cholangiocarcinoma
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.
Tipifarnib Awarded FDA Breakthrough Designation in Head and Neck Squamous Cell Carcinoma
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.
FDA Approves PD-L1 IHC 22C3 PharmDx Assay as Companion Diagnostic for Cemiplimab in NSCLC
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.
Immunotherapy Granted FDA Fast Track Designation in Advanced Ovarian 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.
FDA to Evaluate BLAs for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial 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.
Vicineum Granted FDA Priority Review for Non–Muscle Invasive Bladder 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.
Sotorasib Granted FDA Priority Review for Non-Small Cell Lung 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.
FDA Approves Treatment for Chemotherapy-Induced Bone Marrow Suppression in Small Cell Lung Cancer
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.
FDA to Evaluate Tisotumab Vedotin in Recurrent or Metastatic Cervical 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.
FDA Grants Accelerated Approval to Treatment for Marginal Zone Lymphoma, Follicular Lymphoma
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.
Biologics License Application for Bevacizumab Biosimilar BAT1706
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.
Treatment for Soft Tissue Sarcoma Receives FDA Orphan Drug Designation
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.
FDA Grants Fast Track Designation to Toripalimab for Mucosal Melanoma
The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma.
FDA Grants Priority Review to Treatment for Resected Esophageal or Gastroesophageal Junction Cancer
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.
FDA Grants Priority Review to Treatment for Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy
Narsoplimab is an investigational, fully human IgG4 monoclonal antibody was designed to bind to mannan-binding lectin-associated serine protease-2
FDA Fast Tracks Padeliporfin Immune Photo Activated Cancer Therapy for Upper-Tract Urothelial Cancer
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.
FDA Grants Orphan Drug Designation to BCMA-targeted Multiple Myeloma Therapy
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.
FDA Fast Tracks Cavrotolimod for Merkel Cell Carcinoma
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.
FDA Approves SNDA to Update Label of Darolutamide in Non-metastatic Prostate Cancer
Darolutamide led to a 31% reduction in the risk of death, extending survival for patients with non-metastatic prostate cancer.
FDA Grants Rare Disease Designations to Novel Agent That May Directly Elicit Tumor Cell Death
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.
FDA Grants Breakthrough Designation to Tiragolumab Plus Atezolizumab for NSCLC
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.
FDA Fast Tracks HER2-Positive Metastatic Breast Cancer Drug
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.
CAR T-cell Therapy Application for Large B-cell Lymphoma Remains Under FDA Review
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.
Margetuximab-cmkb Approved by FDA With Chemotherapy for Metastatic HER2-Positive Breast Cancer
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.
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