EMA anticancer drug approvals in 2013
22 January 2014, Raymond Hoffmans
At SMS-oncology, we had a look at the anticancer drugs that were approved by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in 2013. The CHMP approved a total 63 new drugs last year of which 12 are used to treat cancer. For another 18 previously approved drugs the label was extended with a new indication. Three out of these 18 drugs are anticancer drugs.
The majority of anticancer drugs that received an approval were protein kinase inhibitors (7 drugs) followed by immunomodulators (3 drugs). Androgen receptor signaling inhibitors, antibodies, radiotherapeutic drugs, small molecules and taxanes were all represented only once in the list.
It was an exciting year in the prostate cancer field with the approval of three new treatments, namely the androgen receptor signaling inhibitor enzalutamide (Astellas Pharma), the radiotherapeutic drug radium-223 (Bayer Pharma) and the immunomodulator sipuleucel-T (Dendreon). The arsenal of hematologist to treat Philidelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) has been expanded with two new drugs that target the Bcr-Abl fusion protein. Bosutinib (Pfizer) was approved for CML and ponatinib (Ariad Pharma) for CML and ALL. In addition, the first generation Bcr-Abl inhibitor imatinib (Novartis) received a label extension and can now also be used to treat pediatric Ph+ ALL patients.
In 2012, the antibody pertuzumab (Roche) which inhibits the dimerization of HER2 and HER3 receptors was approved for HER2 metastatic breast cancer. In 2013, Roche saw the approval of trastuzumab emtansine for the same indication. This antibody-drug conjugate consists of the monoclonal antibody trastuzumab linked to the cytotoxic agent mertansine. Another approval for Roche in 2013 was that of vismodegib, the first-in-class hedgehog pathway inhibitor, which was approved for the treatment of basal cell carcinoma (BCC).
Celgene had a particularly good year with the approval of one new anticancer drug and the label extension of another two drugs. The immunomodulators pomalidomide and lenalidomide were approved for multiple myeloma (MM) and myelodysplastic syndrome (MDS), respectively, whereas albumin-bound paclitaxel was approved for cancer of the pancreas.
Other drugs approved in 2013 include afatinib (Boehringer Ingelheim) for non-small cell lung cancer (NSCLC), cabozantinib (TMC Pharma) for medullary thyroid carcinoma, dabrafenib (GSK) for melanoma and regorafenib (Bayer Pharma) for colorectal cancer (CRC).
Besides the approval of 12 new anticancer drugs and the label extension into a new oncology indication of another three drugs an additional three drugs received a label change within previously approved indication. Bortezomib (Janssen), ipilimumab (BMS) and lapatinib (GSK) were approved for MM, melanoma and breast cancer, respectively. All three drugs received a positive recommendation from CHMP for a label change within those indications.
Although around 40% of all clinical trials performed are in oncology only 19% of the drugs approved in 2013 were anticancer drugs. This shows once more how challenging oncology drug development can be.