Industry News

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 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 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 6/28/2022

FDA Approves FoundationOne CDx for Entrectinib

On June 9, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne^®CDx as a companion diagnostic for two entrectinib indications:
1. To identify patients with ROS1-positive non-small cell lung cancer
2. To identify patients with neurotrophic tyrosine receptor kinase fusion-positive solid tumors.
Both indications are for patients who may be appropriate for treatment with entrectinib.

For more information, read Foundation Medicine's announcement and Roche's announcement.

Posted 6/9/2022

FDA Approves Two Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma

On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved both nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of programmed death-ligand 1 (PD-L1) status.

For more information, read Bristol Myers Squibb's announcement.

Posted 5/31/2022

FDA Approves Tisagenlecleucel for R/R Follicular Lymphoma

On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.

For more information, read Novartis' announcement.

Posted 5/31/2022

Fam-Trastuzumab Deruxtecan-Nxki Approved for Patients with HER2+ MBC

Fam-Trastuzumab Deruxtecan-Nxki (Enhertu^®, Daiichi Sankyo, AstraZeneca) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

Read press release.

Posted 05/17/2022

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