- Roche may soon secure Food and Drug Administration approval for two of its experimental cancer medicines, announcing on Tuesday the regulator had granted priority review to both entrectinib and polatuzumab vedotin.
- Entrectinib, a targeted cancer drug which Roche acquired in its 2017 deal for Ignyta, is under review by the regulator for the treatment of solid tumors harboring a certain genetic rearrangement, as well as non-small cell lung cancers positive for ROS1 mutations. A decision on approval is set to occur by Aug. 18, 2019.
- If all goes well, entrectinib could be joined on market in the U.S. one day later by polatuzumab vedotin, an antibody drug conjugate aimed at previously treated diffuse large B-cell lymphoma (DLBCL), an aggressive blood cancer. The FDA has set a target action date of Aug. 19, 2019.
Oncology is a mainstay of Roche's pharmaceutical business. Yet its three main cancer drugs — Herceptin (trastuzumab), Rituxan (rituximab) and Avastin (bevacizumab) — are nearing the end of their patent protection. (Biosimilars to Herceptin and Rituxan are available in Europe, but not in the U.S.)
The hastening sales erosion is set to leave a sales gap of as much as $10 billion by 2022, according to a recent presentation from the company. While new drugs like Hemlibra (emicizumab) and Ocrevus (ocrelizumab) are set to play a large role in filling that revenue hole, new cancer drugs will also play a part.
Provided approval follows as scheduled, polatuzumab vedotin and entrectinib could help.
Roche predicts entrectinib's peak revenue potential between $500 million and $1 billion. The targeted therapy could challenge Bayer's Vitrakvi (larotrectinib), which became in November last year only the second cancer drug to be approved by the FDA based only on DNA mutation rather than tumor type. Recent data from late last year, however, appear to show stronger results for Vitrakvi in treating NTRK-fusion positive solid tumors.
The drug could also play a role in ROS1-mutated non-small cell lung cancer, where Pfizer's Xalkori (critzotinib) is currently OK'd.
Polatzumab vedotin would arrive with greater sales hopes, pegged by Roche for blockbuster sales in DLBCL. There, the antibody drug conjugate could compete with recently approved CAR-T cancer therapies, as well as experimental bispecific therapies currently in clinical testing.
In cancer, Roche is also counting on Alecensa (alectinib), Perjeta (pertuzumab) and Venclexta (venetoclax) to serve as successors to Rituxan, Herceptin and Avastin. Replacing three of the most successful biologic cancer therapies, however, will be no easy task.