✅The FDA approved a highly anticipated pancreatic cancer treatment on Wednesday that has altered the prospects for patients facing the deadly disease. The drug, Revolution Medicines’ daraxonrasib, will be marketed as Rasonque for second-line pancreatic cancer patients or patients who are “not candidates for multiagent systemic therapy.”

Rasonque is expected to change the face of pancreatic cancer treatment. Current five-year survival rates sit at 13% and only 3% for late-stage pancreatic cancer, according to the American Cancer Society. Rasonque nearly doubled the median survival times of second-line patients in a Phase 3 trial to 13.2 months, compared to 6.7 months with chemotherapy.

But it’s also one of the most expensive continuous-use cancer drugs on the market. The wholesale acquisition cost is $39,800 for a 30-day supply of the once-daily drug. RevMed expects “a significant proportion of eligible patients to be covered through government payers, particularly Medicare Part D,” CFO Jack Anders said on a Wednesday call with investors. Lei Lei Wu has the full story here. 

RevMed is also studying Rasonque in first-line pancreatic cancer and after surgery, as well as in lung cancer. “We view today not as a finish line, but as the beginning of a much larger opportunity to improve outcomes for patients,” CEO Mark Goldsmith said on Wednesday’s call. 

🤫Lilly decided this spring to stop disclosing its Phase 1 pipeline. It isn’t alone; Merck doesn’t disclose Phase 1 work, and other large global drugmakers are likely to keep several early-stage assets under wraps, BMO Capital Markets analyst Evan Seigerman said. Industry experts shared their mixed thoughts with Endpoints reporter Kyle LaHucik: 

‘Later rather than sooner’: Leerink biopharma analyst David Risinger said that given rising competition, including from China, “it makes sense for Lilly to inform potential competitors later rather than sooner about its emerging pipeline.” It also frees Lilly executives from having to explain Phase 1 decisions or why they’re placing bets in certain areas, said Steve Paul, a former president of Lilly Research Labs.

Public reputation: Jan Lundberg, another former president of Lilly Research Labs, worries that “big pharma is afraid of competition” and that pulling back on pipeline transparency could further erode the industry’s already shoddy reputation with the public. Competition drives efficiency and “really fosters progress,” he said.

What is Lilly working on? Lilly is testing at least five new obesity medicines in Phase 1, according to a search of the company’s active Phase 1 studies on the ClinicalTrials.gov database. The company also has a suite of at least 11 prospects for treating various cancers, three for ALS and three for Alzheimer’s, among other programs. Kyle LaHucik has the details here. 

⚖️The pharma industry suffered a definitive loss in its legal battle against Medicare negotiations this week. On Monday, a DC federal court rejected Merck’s challenge to Medicare drug price negotiations, more than three years after the case was filed. Then on Wednesday, the Fifth Circuit Court of Appeals tossed a challenge brought by the industry trade group PhRMA. They were the last outstanding cases in the industry’s first wave of litigation over the Inflation Reduction Act.

Merck and PhRMA could try to appeal. But to Andrew Twinamatsiko, director of the O’Neill Institute’s Center for Health Policy and the Law at Georgetown University, “it seems like a dead end.” Drugmakers have so far lost every challenge to Medicare negotiations where a judge has ruled on the merits, and the Supreme Court rejected petitions from six other drugmakers earlier this year. Based on those rulings, Twinamatsiko said the future chance of a successful appeal before the Supreme Court is “pretty dim.” You can read my story here. 

💰Roche is spending $190 million upfront to license a non-incretin obesity drug from South Korea’s Hanmi Pharm. Roche’s Genentech unit will get the global rights to Hanmi’s candidate, known as HM17321, except for South Korea. Including milestones, the deal could be worth up to $2.3 billion, with Hanmi also eligible for tiered royalties. The deal is the latest in a string of recent obesity pacts inked by Roche, including its acquisition of Carmot Therapeutics in 2023 and a partnership with Zealand Pharma last year. Ayisha Sharma has the details here. 

🤝Drug developers are on pace to have one of the best dealmaking years in industry history. But so far, only a couple of biotechs have elected to go with an option-to-acquire approach, in which a pharma company pays upfront for the option to eventually buy out the biotech at a predetermined price. That deal structure tends to be more common when capital is constrained and M&A isn’t as robust, Kyle LaHucik wrote this week. He took a deeper look at the strategy, including its appeal and its problems.