There are two major subtypes of lung cancer: Non-Small Cell Lung Cancer (NSCLC), which accounts for 85% of all cases, and Small Cell Lung Cancer (SMLC). About 60% of NSCLC are unresectable at diagnosis, hence, the poor prognosis – ten to twelve months survival when treated with platinum-based chemotherapy. Treatment options are evaluated based on the histologic subtype and the presence of mutations to determine the the best combination of molecular therapies for treatment. Ten to twenty percent of patients with NSCLC have a mutated epidermal growth factor receptor, most commonly. a deletion in the in-frame of exon 19 (around amino acid 747 to 752) or a L858R point mutation of exon 21. On June 1, 2016, the FDA approved the first blood test (liquid biopsy) companion diagnostic to determine whether these mutations are present. Continue reading
Tag Archives: FDA
Kyprolis FOCUS Phase 3 Study for Multiple Myeloma
Last week, Amgen (Onyx) announced negative news from its FOCUS clinical trial of multiple myeloma drug Kyprolis. Let’s put this into perspective. Continue reading
PARP inhibitor rejected by FDA Advisory Committee, then Approved for refractory patients
In June 2014, the FDA Oncology Drug Advisory Committee voted 11-2 to delay approval of AstraZeneca’s olaparib, a PARP (poly-ADP ribose polymerase) inhibitor for maintenance therapy in patients with ovarian cancer. The product received Accelerate Approval designation from the FDA, which provides for conditional approval pending follow-up studies, based on surrogate endpoints from Phase 2 trials, in this case, progression-free survival (PFS). Continue reading
FDA Clinical Hold lifted on telomerase inhibitor
In clinical trials, “clinical holds” are imposed by the FDA when toxicities emerge that are unexpected, either new toxicities that have not been seen before, (or were not anticipated) or increased severity of known or anticipated side effects. The hold allows the FDA to assess the data, demand more data from the sponsoring companies, and make appropriate changes in the study protocol… Continue reading