Industry News Archive

  • FDA Approvees Fam-Trastuzumab Deruxtecan-nxki for HER2-Mutant NSCLC

    On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

    For more information, read the FDA announcement or the AstraZeneca and Daiichi Sankyo announcement.

    Posted 8/15/2022



  • FDA Approves Capmatinib for Metastatic NSCLC

    On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

    For more information, read the FDA announcement.

    Posted 8/15/2022



  • FDA Approves New Acalabrutinib Formulation

    On August 5, 2022, the U.S. Food and Drug Administration approved the new tablet formulation for acalabrutinib for all current indications, including chronic lymphocytic leukaemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.

    For more information, read AstraZeneca's announcement.

    Posted 8/12/2022



  • Important Update: Olaparib in 4th Line Treatment of Ovarian Cancer

    AstraZeneca has issued a letter with plans to withdraw its indication for olaparib (Lynparza) for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. This planned withdrawal will not affect any of the maintenance therapy indications for olaparib or olaparib-based combinations.

    Read the letter

    Posted on 08/11/2022


  • FDA Approves Fam-Trastuzumab-Deruxtecan-nxki for HER2-Low Breast Cancer

    On August 5, 2022, the U.S Food and Drug Administration (FDA) approved fam-trastuzumab-deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-low breast cancer.

    For more information, read the FDA announcement .

    Posted on 8/5/2022



  • FDA Approves Tablet Formulation of Acalabrutinib

    On August 5, 2022, the Food and Drug Administration approved new tablet formulation of acalabrutinib (Calquence, AstraZeneca) under accelerated approval based on overall response rate for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and patients with relapsed or refractory mantle cell lymphoma.

    Read full press release

    Posted on 08/05/2022



  • BMS Launches DDiCT Initiative to Improve Healthcare Outcomes for People with Disabilities

    On July 20, 2022, Bristol Myers Squibb (BMS)—in collaboration with Disability Solutions—announced the launch of the Disability Diversity in Clinical Trials (DDiCT) initiative as part of its mission to address health disparities, clinical trial and supplier diversity, employee giving, and workforce representation between 2020 and 2025. 

    The DDiCT initiative initially aims to make recommendations on how to effectively improve access, engagement, speed of enrollment, and participation of people with disabilities in clinical trials, to ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies.

    For more information, read the press release.

    Posted on 7/21/2022 



  • FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor

    On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib for adult and pediatric patients at least a year old, with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. 

    For more information, read the FDA announcement

    Posted on 7/19/2022 



  • FDA Approves Dabrafenib + Trametinib for Metastatic Solid Tumors

    On June 22, 2022, the U.S Food and Drug Administration (FDA) approved dabrafenib and trametinib for the treatment of adult and pediatric patients 6 years of age and older, with unresectable or metastatic solid tumors with BRAF V600E mutation, who have progressed following prior treatment and have no satisfactory alternative treatment options.

    For more information, read the FDA announcement and the Novartis announcement

    Posted on 6/29/2022


  • FDA Approves Lisocabtagene Maraleucel for Refractory Large B-Cell Lymphoma

    On June 24, 2022, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
    • Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy
    • Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.
    For more information, read the FDA announcement and Bristol Myers Squibb's announcement.

    Posted on 6/28/2022



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