8 years after its OK, Eisai yanks its flailing obesity drug from the market after FDA flagged higher cancer rate

February 13, 2020 04:53 PM EST

8 years after its OK, Eisai yanks its flailing obesity drug from the market after FDA flagged higher cancer rate

Amber Tong

Senior Editor

CAMELLIA-TIMI 61 was supposed to be the trial that would resolve the FDA’s concerns about Belviq as Eisa investigators showed that the weight loss drug didn’t increase incidences of cardiovascular events. Instead, it unearthed new issues that’s now led to its demise.

At regulators’ request, Eisai said it’s withdrawing both the original and extended release version of Belviq from the US market, where it earned a little more than $28 million from April to December 2019.

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What Will it Take to Realize the Promise and Potential of Immune Cell Therapies?

Sartorius Advanced Therapies

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

September 17, 2021 07:26 AM EDTUpdated 07:59 AM

Cell/Gene Tx

FDA+

The biggest questions facing gene therapy, the XLMTM community, and Astellas after fourth patient death

Jason Mast

Editor

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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September 18, 2021 06:00 AM EDTUpdated 01:06 PM

Weekly

Latest news: It’s a no on universal boosters; Patient death stuns gene therapy field; Inside Trillium’s $2.3B turnaround; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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ENDPOINTS CAREERS

Senior Analyst, Oncology

Brass Tacks Health

Remote

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September 19, 2021 10:02 AM EDT

R&D

Mirati's KRAS drug looks like the favorite in colon cancer with new data, putting the pressure square on Amgen

Kyle Blankenship

Managing Editor

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

September 17, 2021 04:59 PM EDT

Coronavirus

Chaotic adcomm sees Pfizer/BioNTech boosters rejected for general population, but recommended for older and high-risk populations

Max Gelman

Editor

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

September 19, 2021 01:09 PM EDT

R&D

The best of the rest: Highlights from the below-the-fold presentations at #ESMO21

Kyle Blankenship

Managing Editor

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

September 18, 2021 09:05 AM EDTUpdated 38 minutes ago

R&D

AstraZeneca, Daiichi Sankyo's ADC Enhertu blows away Roche's Kadcyla in second-line advanced breast cancer

Kyle Blankenship

Managing Editor

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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ENDPOINTS CAREERS

Senior Scientific Research Analyst

American Association for Cancer Research

Philadelphia, PA, USA

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Merck Research Laboratories CMO Roy Baynes

September 18, 2021 09:05 AM EDT

R&D

Merck's Keytruda uncorks full data on latest adjuvant win — this time in melanoma — adding bricks to early cancer wall

Kyle Blankenship

Managing Editor

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

September 16, 2021 07:18 AM EDT

FDA+

Takeda scores a win for a rare type of lung cancer, gearing up for a showdown with J&J

Nicole DeFeudis

Editor

Four months after J&J’s infused drug Rybrevant scored the industry’s first win in a rare type of non-small cell lung cancer (NSCLC), Takeda is following up with an oral option for the small but desperate patient population.

The FDA granted an accelerated approval to Takeda’s oral TKI inhibitor Exkivity (mobocertinib) in metastatic NSCLC patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, the company announced on Wednesday.

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