On Friday, July 9th, the Oncologic Drugs Advisory Committee (ODAC), suggested that necitumumab (Lilly), a monoclonal antibody.
On Friday, July 9th, the Oncologic Drugs Advisory Committee (ODAC), suggested that necitumumab (Lilly), a monoclonal antibody, shows promise in the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin.
Necitumumab is a monoclonal antibody that binds to the extracellular domain of the human epidermal growth factor receptor (EGFR) and blocks interaction between EGFR and its ligands. As noted by the makers of necitumumab, EGFR expression is high in NSCLC tumors, and is found in more than 95% of squamous NSCLC.
The Committee did not vote on whether necitumumab should be approved; however, most members of the committee noted that it had a favorable risk-benefit profile despite safety concerns, which included the appearance of more sudden and unexplained deaths in patients who were taking the drug.
In the pivotal study, SQUIRE, there was a 1.6-month improvement in median overall survival, and a 0.2-month improvement in median progression-free survival with the addition of necitumumab to gemcitabine and cisplatin (Neci + GC) when compared to the gemcitabine-cisplatin (GC) regimen. Median overall survival was 11.5 months for Neci + GC, compared with 9.9 months for GC alone, and the median progression-free survival was 5.7 months, compared with 5.5 months.
ODAC chair Deborah K. Armstrong, MD, professor of oncology at the Johns Hopkins University in Baltimore, Maryland noted, “I think the survival benefit is modest, but real.”
Several patient advocates who spoke during the public portion of the meeting urged the panel to support approval of necitumumab, noting that there are few options for treatment of squamous NSCLC.
Squamous tumors make up about a third of all lung cancers, and are primarily due to heavy tobacco use, but not always. The majority of patients with the squamous form present with locally advanced or metastatic disease, stated the FDA. Five-year survival is less than 5%, according to the Agency.
A decision regarding the approval of necitumumab is expected later in 2015.
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.
Do you have an upcoming Advisory Committee Meeting?
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us