Pfizer Inc., the New York-based pharmaceutical company, has reportedly announced that its third-generation lung cancer drug LORBRENA has been approved by the U.S. Food & Drug Administration (FDA).
Reports cite, the drug – an ALK TKI (Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitor) – is designed for individuals suffering from metastatic Non-Small Cell Lung Cancer (NSCLC) that is ALK-positive.
According to a press release by the company, the drug’s target demographic includes individuals whose NSCLC has progressed on crizotinib as well as one other ALK inhibitor at the least for metastatic disease; or individuals whose condition has progressed on ceritinib or alectinib as the first therapy using ALK inhibitor for metastatic diseases.
Reportedly, this indication received approval under accelerated approval based upon its tumor response rate as well as the duration of the response. This indication’s continued approval may depend upon clinical benefit description and verification in a confirmatory trial in the future.
The Pfizer Oncology Global President, Andy Schmeltz stated that over the years, the company has transformed the management, research as well as the treatment for people suffering form ALK-positive NSCLC. Schmeltz further added that the LORBRENA was discovered with the help of this experience by company scientists and will benefit individuals suffering with ALK-positive NSCLC who have progressed on from prior treatments, thus successfully delivering on the firm’s commitment to meet the needs of cancer patients that were previously unmet.
For the record, while many individuals diagnosed with ALK-positive metastatic NSCLC respond well to initial TKI treatment therapy, they commonly experience tumor progression. Treatment options for patients who progress after receiving second-generation ALK TKI treatments, brigatinib, ceritinib and alectinib, are very limited. The discovery and approval of LORBRENA provides a new option to patients that have progressed on the second-generation ALK TKI to stay on oral treatment therapy.
This announcement reportedly marks the third instance where Pfizer Inc. has received approval from U.S. FDA within two months for an oncology treatment, with the first two approvals being for lung cancer medicines.