- Swiss pharma Novartis secured the backing of a key European Medicines Agency panel in favor of approval of its breast cancer drug Kisaqali (ribociclib), setting up a potential entry to the EU market for the key CDK 4/6 inhibitor in the coming months.
- The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended approval of Kisqali, combined with an aromatase inhibitor, for first-line treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer.
- The CHMP was busy in June, supporting approval for four other novel drugs, two generics and one biosimilar in its monthly meeting from June 19 to June 22. The European Commission usually follows the EMA's recommendations in authorizing marketing.
Novartis has high hopes for Kisqali, pegging the drug for potential blockbuster sales. Along with the company's CAR-T hopeful and expanded indications for drugs like Taflinar (dabrafenib) and Mekinst (trametinib), Kisqali is a cornerstone of Novartis' plans for new growth in oncology.
This is particularly true as sales of Novartis' top-selling cancer drug Gleevec (imatinib) continue to erode due to generic competition.
Kisqali locked up a similar first-line approval from the Food and Drug Administration in March, giving Novartis a competing offering to Pfizer's fast-growing blockbuster Ibrance (palbociclib). Eli Lilly is advancing quickly with its own CDK 4/6 inhibitor abemaciclib, potentially a third player in the space.
But Pfizer's Ibrance will be tough competition, having already secured a 45% market share in first-line treatment of HR+/HER2- metastatic breast cancer. Novartis priced Kisqali competitively, at a wholesale acquisition cost of $10,950 for a month's supply of the 600 mg high dose and $4,380 for a 200 mg low dose — prices Novartis describes as cheaper than Ibrance's list price.
Other EMA decisions
Notably, the CHMP recommended approval for Aveo Oncology's tivozanib in kidney cancer. News of the panel's backing drove up Aveo stock more than 70% to close at $1.25 in Friday trading.
If licensed by the European Commission in the coming months, tivozanib would be indicated for first-line treatment of advanced renal cell carcinoma.
Aveo has faced a long road in developing tivozanib, which was rejected by the FDA in June 2013. Other roadblocks, including a $4 million settlement with the Securities and Exchange Commission and a Phase 2 failure of another cancer drug, pushed Aveo shares down into penny-stock territory. Securing authorization for tivozanib in the EU would make the drug Aveo's first marketed product and allay some of its cash concerns.
EC licensure would trigger a $4 million payment from EUSA Pharma, a specialty pharma to which Aveo licensed EU commercial rights to tivozanib. Further progress in winning member state reimbursement and other regulatory approvals would trigger another $12 million in milestone payments from EUSA, Aveo said.
That cash is needed, too. A filing with the Securities and Exchange Commission for the first quarter noted Aveo will need $10 million in unrestricted cash until completion of the TIVO-3 study in order to maintain financial covenants under a loan agreement with Hercules Technology, a venture debt provider. Current cash holdings sit at $33.4 million as of March 31.
Elsewhere, the CHMP recommended approval of Samsung Bioepis' biosimilar version of AbbVie's best-selling Humira (adalimumab), as well as a mutliple sclerosis drug from Merck KGaA and two hepatitis C treatments developed by AbbVie and Gilead, respectively.