The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.
The FDA said in a statement that the meeting ‘is no longer needed’ but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.
ODAC was set to discuss Secura Bio’s Farydak (panobinostat), a third-line multiple myeloma drug, and Acrotech Biopharma’s Marqibo, a third-line drug for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia. Both drugs have been marketed for more than five years under their accelerated approvals but have recorded negligible sales in their respective indications in recent years.
In the case of Farydak, Novartis won the initial accelerated approval in 2015 but said it likely wouldn’t start the confirmatory trial for almost three years, and the FDA gave the company until this year to finish both of its requirements. In March 2019, Secura Bio bought the drug from Novartis, but annual sales have fallen below $100 million recently.
In the case of Marqibo, Talon Therapeutics initially won the accelerated approval in 2012 based on data from a single Phase II trial. Spectrum Pharmaceuticals then acquired Talon and the drug for about $11 million in 2013. In 2018, Spectrum reported about $5.5 million in Marqibo sales, and then proceeded to sell the drug a year later with six other cancer drugs to Aurobindo Pharma’s subsidiary Acrotech for $160 million upfront.
Meanwhile, Talon had initially agreed to submit the results of its confirmatory trial to the FDA more than three years ago, but it remains unknown if that submission occurred.
The push to review these two dangling accelerated approvals followed another ODAC meeting last summer to review six other indications, four of which the committee ended up recommending remain on the market. Since then, three indications have been pulled voluntarily by the companies, and one has gone on to nab a full approval.
While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.
Stéphane Bancel, Moderna CEO
Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.
Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?
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GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.
Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.
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After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).
The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.
Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.
As a result, 140 of its staffers will be laid off.
The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a ‘select number of key European markets.’
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Mark Enyedy, ImmunoGen CEO
When ImmunoGen’s lead antibody-drug conjugate flunked a Phase III study in ovarian cancer a couple years ago, the company clung to hope that it would perform better in a subgroup of patients with high folate receptor alpha (FRα) expression.
On Tuesday, researchers uncorked topline Phase III results suggesting it was right — and investors cheered on the news with a 40% boost to ImmunoGen’s stock price $IMGN. CEO Mark Enyedy says he’s going after an accelerated approval and plans to file in the first quarter of 2022.
Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.
The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.
Drug developers at Gilead Sciences are moonlighting as college professors these days. However, it’s not a side hustle for extra income, but a new program to help draw Black and Hispanic students to the industry.
Chemists, manufacturing experts, biologics scientists and supply chain managers are just some of the employee teachers Gilead is enlisting to explain the pharma business from drug discovery to commercialization.
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