This week the FDA granted quite a few approvals for line extensions of Lilly (LLY - Free Report) , Pfizer (PFE - Free Report) and Roche (RHHBY - Free Report) /AbbVie’s (ABBV - Free Report) cancer drugs. In other news, Bayer (BAYRY - Free Report) was fined $2 billion by California jury over allegations that its popular weed killer caused cancer. J&J (JNJ - Free Report) detailed a new five-year growth plan for its Pharmaceutical segment, its largest unit, at its analyst day.
Recap of the Week’s Most Important Stories
Lilly’s Cyramza Gets FDA Nod for New Indication: The FDA granted approval to Lilly’s cancer drug Cyramza for the second-line treatment of patients with hepatocellular carcinoma (HCC), a common form of liver cancer. Importantly, along with this approval, the FDA also removed the boxed warning from Cyramza’s label, which included warnings for hemorrhage, ruptured bowel and non-healing wounds. The approval for HCC was based on data from the REACH -2 study. Cyramza is already marketed for other cancer indications like gastric cancer, non-small cell lung cancer (NSCLC) and metastatic colorectal cancer.
Pfizer Gets FDA Nod for Bavencio+Inlyta Combo in Kidney Cancer: Pfizer and partner Merck KGaA gained FDA approval for Bavencio (avelumab) in combination with Inlyta (axitinib) for first-line treatment of patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer. The FDA’s decision comes earlier than expected. The decision was originally scheduled in June. A similar application is under review in the EU, which was validated for review by the European Medicines Agency this March. The regulatory filings in the EU and the United States were based on interim data from the phase III JAVELIN Renal 101 study, which showed that the Bavencio/Inlyta combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months versus Pfizer’s older kidney cancer drug, Sutent.
Moreover, Pfizer’s investigational JAK1 inhibitor abrocitinib (PF-04965842) met all co-primary and secondary endpoints in a pivotal late-stage study. In the phase III study, which tested two doses of the drug, abrocitinib achieved statistically significantly higher improvement in clearing the skin of patients compared to placebo.
FDA Grants Approval to Venclexta+Gazyva in First-Line CLL: The FDA granted approval to a combination of AbbVie/Roche’s Venclexta and Roche’s Gazyva as a fixed duration treatment for first-line chronic lymphocytic leukemia (CLL). The approval was based on data from the phase III CLL14 study, which demonstrated that the combination significantly reduced risk of disease progression or death by 67% compared to the current standard of care. The supplementary new drug application was filed under the Real-Time Oncology Review (RTOR) pilot program, which meant that the agency expedited the review.
Data from a phase I/II study on Roche’s personalized medicine entrectinib showed that the candidate had an objective response or shrank tumors harboring NTRK, ROS1 or ALK gene fusions including those in the central nervous system (CNS) in children and adolescents. Moreover, two patients achieved a complete response. The data will be presented at the ASCO meeting in June.
Bayer Fined $2B by a California Jury: A California state jury ordered Bayer to pay $2 billion in damages to a couple, Alva and Alberta Pilliod, who claimed the company’s Roundup weed-killer was the cause of their cancer. The active ingredient in Roundup, glyphosate, is being blamed for causing the cancer. This is the third jury verdict against Bayer in litigation over the herbicide, which Bayer acquired as part of its $63 billion buyout of Monsanto last year. However, Bayer is disappointed with the verdict and said will appeal against the verdict.
J&J’s Analyst Day: At its meeting with industry analysts, J&J said it expects its Janssen pharmaceutical business to deliver above-market growth through 2023. J&J expects to launch or file for approval of more than 10 new products with blockbuster potential between 2019 and 2023. J&J said it has gained regulatory approvals for 18 new products since 2011 in HIV, cancer and cardiovascular areas. The company is targeting more than 40 line extensions of existing and new drugs through 2023, 10 of which have more than half a billion dollars of opportunity. However, the unit’s growth is expected to be a little bit slow in 2019 due to more than $3 billion of patent expirations that it is currently facing.
AbbVie Resolves U.S. Patent Litigation With Boehringer Ingelheim: AbbVie announced resolution of its litigation with Boehringer Ingelheim over U.S. patents for its blockbuster rheumatoid arthritis drug Humira. Per the settlement, AbbVie grants Boehringer Ingelheim a non-exclusive license to launch its biosimilar version of Humira in the United States on July 1, 2023. Several companies have made biosimilar versions of Humira. AbbVie has similar settlement with seven manufacturers, per which Humira biosimilars are expected to be launched in the United States in 2023. In the EU, however, Humira biosimilars have already been launched, which are causing a rapid decline in Humira sales in international markets.
The NYSE ARCA Pharmaceutical Index rose 0.1% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
Last week, in a mixed performance, Pfizer gained the most (2.5%) while AstraZeneca declined the most (1.7%)
In the past six months, Merck (MRK - Free Report) has been the biggest gainer (3.7%) while Bristol-Myers declined the most (11.8%).
(See the last pharma stock roundup here: Pharma Stock Roundup: AGN, NVO Report Q1 Earnings, NVS to Buy Takeda’s Eye Drug)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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