In 2015, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 39 new active substances. One third of those were for the treatment of cancer. Like in the US, Non Small Cell Lung Cancer (NSCLC) and Melanoma benefited the most from new drugs approvals. Of the 4 new drugs approved in the US for relapsed and refractory multiple myeloma in 2015, however, only one was approved in Europe. We review here in more details newly approved oncology drugs.
Across Lung Cancer, Melanoma and Multiple Myeloma, patients in Europe have now 9 new drugs available, increasing their treatment options.
4 new drugs were approved against various targets in Non Small Cell Lung Cancer (NSCLC): PD-1, EGFR, IGF-1R. They are mAbs or Tyrosine Kinase inhibitors.
AstraZeneca’s osimertinib Tagrisso was recommended for approval in December 2015 and granted conditional marketing authorization in February 2016. It was reviewed under the accelerated approval program. It is indicated in NSCLC patients with EGFR T790M mutation positive, irrespective of previous treatment with an EGFR tyrosine kinase inhibitor (TKI).
Novartis’s ceritinib Zykadia was recommended for approval in February 2015 and granted conditional marketing authorization in May 2015. It is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib.
Merck’s pembrolizumab Keytruda, a mAb against PD-1 and Lilly’s necitumumab Portrazza, a mAb against EGFR were also approved in NSCLC.
Bristol-Myers Squibb’s nivolumab Opdivo is the first PD-1 mAb approved for melanoma in Europe.
Other remarkable approvals are Genentech’s cobimetinib Cotellic, a MEK inhibitor, approved in late 2015 first in the USA and a month later in the EU for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, to be used in combination with vemurafenib and Amgen’s Talimogene Laherparepvec Imlygic the first genetically modified oncolytic viral therapy approved in December 2015.
Novartis’s Farydak (panobinostat) was approved in 2015 in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. It is a First in Class histone deacetylase (HDAC) inhibitor with epigenetic activity available in the European Union.
Three Multiple Myeloma drugs were approved in the US and not in Europe.
Amgen’s carfilzomib Kyprolis was finally approved in Europe in 2015 in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. It was reviewed under the accelerated approval program. Of note, it was approved by the FDA almost 4 years (July 2012) in patients with multiple myeloma who had received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy.
Amgen’s blinatumomab Blincyto was granted conditional marketing authorization in November 2015. It is indicated in relapsed refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL. It also has a black triangle warning, which means it will be monitored very closely by the health care authorities after launch.
Other new oncology drugs
Lenvima in Thyroid tumors, Odomzo in locally advanced basal cell carcinoma and Unituxin in pediatrics neuroblastoma were also approved last year. For more details, the EMA publishes the list of new drugs every year.