FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor

FDA Approves Dabrafenib + Trametinib for Metastatic Solid Tumors

FDA Approves Lisocabtagene Maraleucel for Refractory Large B-Cell Lymphoma

• 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.
  

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

FDA Approves Ivosidenib in Combination for Acute Myeloid Leukemia

On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test, in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.

Read the FDA announcement.

Read Servier's announcement.

Posted 5/26/2022

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

FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma

FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Prostate Cancer

On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. 

Read the FDA announcement.

Read Novartis' announcement.

Posted 3/24/2022