In 2016, the US FDA approved 22 new drugs, the number is the lowest for the ten years. In the first half of 2017, the US FDA had approved 23 new drugs, the number is more than the sum of 2016. Up to now, FDA has approved 34 new drugs, including 11 anti-cancer drugs.
Ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) and abemaciclib (Verzenio, Eli Lilly and Company) are widely-watched new drugs for treating breast cancer. The two drugs are cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Niraparib (Zejula, Tesaro, Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Brigatinib (Alunbrig tablets, Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Midostaurin (Rydapt, Novartis Pharmaceuticals Corp.) was approved for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+). This is a major breakthrough in the recent 25 years.
Abemaciclib – CAS 1231929-97-7
Midostaurin – CAS 120685-11-2
On March 13, 2017, the U.S. Food and Drug Administration approved ribociclib for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is the second cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved by FDA. The first is palbociclib (Ibrance, Pfizer Inc.). It is very successful in marketing. Sales in its first year (2015) were $723 million. In 2016, sales are up to $2.135 billion. Peak sales are expected to reach $6 billion in the next five years. Compared to palbociclib (Ibrance), ribociclib (Kisqali) have no obvious advantages. So the peak sales are expected reach $1.4 billion. On September 28, 2017, the FDA approved abemaciclib (Verzenio, Eli Lilly and Company) in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. Compared to the two CDK4/6 inhibitors, abemaciclib has no special. Peak sales are expected the to reach $200 million in the next five years.
Palbociclib – CAS 827022-33-3
There are five PD-1/PD-L1 monoclonal antibody come into the market now, including pembrolizumab (Keytruda, Merck & Co., Inc.), nivolumab (Opdivo, Bristol-Myers Squibb Company), atezolizumab (Tecentriq, Genentech Oncology), avelumab (Bavencio, EMD Serono, Inc.) and durvalumab (Imfinzi, AstraZeneca UK Limited). On March 23, 2017, the FDA granted accelerated approval to avelumab for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Peak sales are expected to reach $1 billion in the next five years. Durvalumab was approved on May 1, 2017. Except bladder cancer, durvalumab was used more than twenty clinical research programs. Peak sales are expected to reach $3 billion in the next five years.
On March 27, 2017, the FDA approved niraparib (Zejula, Tesaro, Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Niraparib was the third approved PARP inhibitor after olaparib (Lynparza, AstraZeneca) and rucaparib (Rubraca, Clovis Oncology Inc.). Compared to the two PARP inhibitors, niraparib has the obvious advantages. So the peak sales are expected to reach $1.3 billion in the next five years.
Rucaparib – CAS 283173-50-2
On April 28, 2017, the FDA granted accelerated approval to brigatinib for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. There are three second generation ALK inhibitor come into the market now, including ceritinib (Zykadia, Novartis Pharmaceuticals Corp.), alectinib (Alecensa, Genentech, Inc.) and Brigatinib (Alunbrig tablets, Takeda Pharmaceutical Company Limited). The peak sales are expected to reach $100 million in the next five years.
On April 28, 2017, the FDA approved midostaurin (Rydapt, Novartis Pharmaceuticals Corp.) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. It is worth mentioning that midostaurin is the first approved drug to treat the condition. The peak sales are expected to reach $400 million in the next five years.