Boehringer Ingelheim’s nintedanib has been granted PIM—Promising Innovative Medicine—status for the treatment of malignant pleural mesothelioma (MPM) in the United Kingdom (UK) by the country’s Medicine and Healthcare Products Regulatory Agency. PIM status signifies that nintedanib has potential to be available to patients in the UK with MPM, a life-threatening illness, before it is approved for this indication in Europe. The UK’s Early Access to Medicines Schemes aims to get promising new drugs to patients with acute illnesses that present with a poor prognosis in advance of a drug’s official regulatory approval.
MPM is a rare and aggressive form of cancer that affects the pleura—a thin membrane of cells that line the lungs and chest wall. This cancer type typically offers patients a poor prognosis with a median survival in the range of eight-14 months from time of diagnosis. MPM is most often attributed to exposure to the naturally-occurring mineral asbestos.
Clinical and non-clinical data collected from the Phase II LUME-Meso Trial played a large role in nintedanib being awarded PIM status. Results of this trial demonstrated statistically significant improvements in progression-free survival (PFS) in MPM patients treated with nintedanib plus chemotherapy compared to the same classification of patients receiving chemotherapy alone—9.4 months vs. 4.7 months, respectively.
Chair of Thoracic Medical Oncology at the University of Leicester and University Hospitals of Leicester NHS Trust in the UK, Professor Dean Fennell, commented on nintedanib’s PIM status: “This is fantastic news and the right decision taking into account the risk/benefit profile of nintedanib from a very credible Phase II trial.”
The safety and efficacy of nintedanib will continue to be assessed in patients with unresectable MPM during Phase III of the LUME-Meso trial which is now recruiting patients at trial sites internationally.
Nintedanib is currently marketed under the brand name Vargatef® which is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first-line chemotherapy and under the brand name Ofev® for the treatment of idiopathic pulmonary fibrosis (IPF).Sources
Pharma Times Online. PIM Status for Boehringer’s Mesothelioma Drug. January 4, 2018.
ClinicalTrials.gov. Nintedanib (BIBF 1120) in Mesothelioma.