FDA Approves FoundationOne Liquid CDx as Companion Diagnostic for Mobocertinib

On May 4, the U.S. Food and Drug Administration (FDA) approved the FoundationOne^®Liquid CDx to be used as a companion diagnostic for mobocertinib, which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.

For more information, read the Foundation Medicine announcement. 

Posted 5/4/2023

Novartis ribociclib only Category 1 preferred first-line treatment option for HR+/HER2- mBC in combination with an AI in updated NCCN Clinical Practice Guidelines in Oncology

East Hanover, March 28, 2023 — Updates to the NCCN Guidelines® for breast cancer, released in January 2023, recommend ribociclib (Kisqali®) as the only Category 1 preferred CDK4/6 inhibitor (CDK4/6i) for first-line treatment of patients with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC) when combined with an aromatase inhibitor (AI). This recommendation indicates high levels of clinical evidence and uniform consensus among NCCN on ribociclib (Kisqali) as an appropriate treatment.

NCCN Guidelines also continue to recommend ribociclib (Kisqali) plus fulvestrant as a Category 1 preferred regimen for first- and subsequent-line therapies* in HR+/HER2- mBC.

The latest NCCN Guidelines recommend ribociclib (Kisqali) for demonstrating significant overall survival (OS) benefit in combination with various endocrine therapies across three Phase III MONALEESA trials in HR+/HER2- mBC and uniquely in combination with an AI in the first-line setting in MONALEESA-2. These recent updates to the guidelines reinforce key distinctions among the CDK4/6i in mBC, driving the potential to enhance patient access to the latest evidence-based care and to improve outcomes.

In addition to consistently demonstrating statistically significant OS benefit, Kisqali preserved or improved patients’ quality of life in all three Phase III MONALEESA trials.

For more information read the Novartis announcement.

Posted 5/4/2023

FDA Approves Enfortumab Vedotin-ejfv + Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

On April 3, U.S the Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

For more information read the FDA announcement, the Merck announcement and the Seagen announcement. 

Posted 4/3/2023

FDA Approves Dabrafenib + trametinib for Pediatric Patients with LGG

On March 16, 2023, the U.S Food and Drug Administration (FDA) approved dabrafenib with trametinib for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

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

Posted 3/20/2023

FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

On February 3, 2023, the U.S. Food and Drug Administration (FDA) approved Trodelvy^® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

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FDA Approves Pembrolizumab as Adjuvant Treatment for NSCLC

On January 26, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

For more information read the FDA announcement and the Merck announcement. 

Posted 1/27/2023

FDA Approves Zanubrutinib for CLL or SLL

On January 19, 2023, the U.S Food and Drug Administration (FDA) approved zanubrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

For more information, read the FDA announcement and the Beigene announcement. 

Posted 1/20/2023

FDA Approves FoundationOne Liquid CDx for Some Tyrosine Kinase Inhibitors in NSCLC

On December 21, Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) approved its FoundationOne^®Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors approved by the FDA for this indication.

For more information, read Foundation Medicine's press release.

Posted 12/21/2022

FDA Approves a New Dosing Regimen for Asparaginase Erwinia Chrysanthemi

On November 18, 2022, the U.S Food and Drug Administration (FDA) approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn. Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. 

For more information, read the FDA announcement.

Posted 11/21/2022

FDA Approves Tremelimumab with Durvalumab + Chemotherapy for Metastatic NSCLC

On November 10, 2022, the U.S Food and Drug Administration (FDA) approved tremelimumab in combination with durvalumab and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase genomic tumor aberrations.

For more information, read the FDA announcement.

Posted 11/15/2022