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Bio Roundup: Hope for Lungs, Bradner’s Complaint, FDA Nods & More

Xconomy National — 

The biggest news this week was in oncology, hands down. Merck showed that its immunotherapy pembrolizumab (Keytruda) might become a common option for many patients newly diagnosed with advanced lung cancer, but the bigger picture is that the field is moving fast. While pembrolizumab notched the headline-grabbing data, others are also working to develop options for various subsets of patients.

Who will be able to afford all these options? We explored that question in our coverage. The price of drugs is certainly on a lot of minds these days, including the mind of President Trump, as he reportedly will make a major speech on drug prices next week, which raises this question for us: Will there be any fire this time, or just more smoke?

Meanwhile, back in Trump’s hometown… the old biomedical saying goes something like “we’ve cured cancer in a million mice”—and this is the thanks we get. (Rodents in New York City are disgusting? Who knew?)

We’ll start the roundup with attempts to cure cancer in humans, and move on to regulatory wins and losses, a pharma M&A fight, and more. Let’s get to it.

THE BIG C

—Amid the raft of late-stage lung cancer data released at the American Association for Cancer Research meeting in Chicago, Merck (NYSE: MRK) showed that its pembrolizumab combined with chemotherapy cut in half the risk of death or worsening disease when given to newly diagnosed patients. Rival Bristol-Myers Squibb (NYSE: BMY) showed promising data for patients whose tumors have unusually high levels of DNA mutations, but its study came with more caveats than Merck’s, as Xconomy reported. Other immunotherapy studies are pushing the boundaries of treatment, perhaps relegating chemotherapy to the sidelines for some patients, and lung specialists are bracing for expanded treatment options that come with high price tags.

—Lung cancer showdown aside, there were plenty of other news tidbits emerging from AACR. Xconomy rounded up some of the other headlines, including advances in targeted cancer medicines, cell therapies, immunotherapy combinations and more.

—Its shares took a beating during AACR, but Bristol managed to notch a regulatory victory. The FDA approved its nivolumab-ipilimumab combination for newly diagnosed, advanced “intermediate and poor risk” kidney cancer patients, which Bristol says includes about 75 to 80 percent of people with the disease. It’s the second FDA nod for nivo-ipi, which is already approved for melanoma.

—-The FDA approved AstraZeneca’s (NYSE: AZN) osimertinib (Tagrisso) for newly diagnosed advanced lung cancer patients whose tumors have an EGFR mutation. Osimertinib bested other EGFR-targeting drugs erlotinib (Tarceva) and gefitinib (Iressa) in a study, FLAURA, published in the New England Journal of Medicine in January.

—In a blog post, Jay Bradner, the former head of Dana-Farber Cancer Institute and the current president of Novartis Institutes for Biomedical Research, wrote that too many investment dollars have gone into redundant cancer programs, such as more checkpoint inhibitors, rather than going after tougher drug targets that might have a greater future impact.

—In a move that sharpens its focus on rare diseases, Shire (NASDAQ: SHPG) reached a deal to sell its oncology business to France-based Servier for $2.4 billion cash. With a market value near $50 billion, Shire then rejected a $63 billion takeover offer from Takeda Pharmaceutical. Another drug giant, Allergan (NYSE: AGN), confirmed to Reuters that it had considered a bid, as well, but decided to end it after shareholder pushback.

THE FDA SAYS…

—-Ultragenyx (NASDAQ: RARE) won FDA approval for burosumab (Crysvita), an antibody drug to treat the bone-weakening disorder X-linked hypophosphatemia. Novato, CA-based Ultragenyx set a $200,000 annual price for adults taking the drug; $160,000 for children.

–Two weeks after declining to review depression drug ALKS-5461 and asking owner Alkermes (NASDAQ: ALKS) to conduct a new clinical trial, the FDA reversed its ruling and set a new target date for an approval decision.

—The FDA approved the Rigel Therapeutics (NASDAQ: RIGL) drug fostamatinib disodium hexahydrate (Tavalisse) to treat chronic immune thrombocytopenia, a condition in which the immune system destroys the body’s own platelets.

—An FDA staff review of rheumatoid arthritis drug baricitinib questioned whether Eli Lilly (NYSE: LLY) provided enough information about safety and its benefit to patients at two different doses. Similar concerns sank the company’s application for approval last year. An FDA advisory panel is set to discuss the resubmitted drug application on Monday.

—Solid Biosciences (NASDAQ: SLDB) received an FDA letter explaining how to restart a study of its Duchenne muscular dystrophy gene therapy SGT-001, which the FDA halted due to safety concerns in March. Solid plans to respond “in the coming weeks.”

OF MICE AND DATA

— As a decision date for migraine drug erenumab (Aimovig) looms next month, its owner Amgen (NASDAQ: AMGN) rolled out full Phase 3b results. Erenumab hit the main goals of reducing headache frequency in episodic migraine patients who had previously failed at least two other treatments.

—The NEJM published updates from two early-stage Bluebird Bio (NASDAQ: BLUE) studies of a gene therapy for the rare disease beta-thalassemia, which requires patients to … Next Page »

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