FDA

New FDA Appointee Is Likely to Emphasize Real-World Data

President Joe Biden recently nominated former FDA Commissioner Robert Califf, M.D., to run the agency once more, ending nearly a year of temporary leadership under Acting Commissioner Janet Woodcock, M.D. One insider says that Califf might look to reform and improve the accelerated approval pathway following the controversial Aduhelm (aducanumab) approval earlier this year.

Califf previously led the FDA during the Obama administration, running the agency for roughly the last two years of Obama’s term. Califf advocates for using “real-world evidence” in addition to clinical trial data in medical approvals. Aduhelm, an Alzheimer’s drug, was approved without such data, though studies of the drug relying on real-world evidence — which takes into account electronic medical record and insurance claims data — are underway. During Califf’s initial tenure, Sarepta Therapeutics’ eteplirsen, a muscular dystrophy drug, also earned accelerated approval despite a large outcry from medical researchers.

Insurers Get Their Wish With Repeal of Medical Device Rule

CMS repealed a proposed Trump-era regulation that would have required Medicare to cover experimental “breakthrough” medical devices that have been approved by the FDA but not cleared for Medicare use through a national coverage determination. Insurer groups opposed the rule and urged the Biden administration to revoke it, while the medical device industry’s largest trade group championed it as a breakthrough for patients.

“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries. The Medicare program needs to implement policies that balance access and appropriate safeguards,” said CMS Administrator Chiquita Brooks-LaSure in a Nov. 12 press release on the decision. CMS said it will begin to develop an alternative policy to ensure speedy access to breakthrough technologies.

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FDA Grants Interchangeable Status to Humira Biosimilar, but Certain Factors May Hamper Its, Other Adalimumabs’ Uptake

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

On Oct. 15, 2021, the FDA granted interchangeability status to Cyltezo for all of its approved uses. Boehringer Ingelheim’s Phase III VOLTAIRE-X clinical trial found no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety over multiple switches between Humira and Cyltezo. Per the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the drug will have one year of exclusivity upon launch during which the FDA cannot grant interchangeable status to another Humira biosimilar.

Oncologists Show Interest in Prescribing New CML STAMP Inhibitor Scemblix

The FDA recently approved a first-in-class agent for the treatment of chronic myeloid leukemia (CML). Oncologists showed much more interest in the agent than did payers when Zitter Insights surveyed both stakeholder groups.

On Oct. 29, the FDA approved Novartis Pharmaceuticals Corp.’s Scemblix (asciminib) for the treatment of CML in two indications: (1) adults with Philadelphia chromosome-positive CML in chronic phase previously treated with at least two tyrosine kinase inhibitors (TKIs), which was given accelerated approval, and (2) adults with PH+ CML-CP with the T315I mutation, which was granted full approval. It is the first FDA approval of a CML therapy that is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor.

Eli Lilly Pounces on Flailing Aduhelm With Competing Drug

Eli Lilly & Co. has announced plans to run a head-to-head clinical trial of its Alzheimer’s drug, donanemab, against Aduhelm (aducanumab), the controversial Biogen Inc. Alzheimer’s drug. Meanwhile, Aduhelm has continued to have what one expert calls “the worst drug launch ever,” after state Medicaid leaders told CMS they want no part of paying for the drug.

In its third-quarter results, Biogen reported in a Securities and Exchange Commission filing that Aduhelm revenues totaled $300,000, citing the fact that many clinicians don’t want to prescribe the drug. Meanwhile, Eli Lilly & Co.’s donanemab is under an accelerated approval process. That process will include a Phase III study comparing donanemab directly to Aduhelm, according to Daniel Skovronsky, M.D., Ph.D., a Lilly senior vice president and its chief scientific and medical officer.

FDA Grants Interchangeable Status to Humira Biosimilar; Payers Should Prepare Now for 2023 Launches

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

New Tecartus FDA Approval for Adults With ALL Offers Welcome Therapeutic Option

On Oct. 1, the FDA gave another indication to Gilead Sciences, Inc. division Kite Pharma, Inc.’s Tecartus (brexucabtagene autoleucel) for the treatment of people 18 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). According to a Zitter Insights survey, oncologists said they are likely to prescribe the drug over certain therapies for that indication. Industry experts tell AIS Health, a division of MMIT, that the agent may be a game changer for certain patients, as it fills a treatment gap.

New FDA Approvals: FDA Grants Additional Approval to Verzenio | Nov. 16, 2021

Oct. 13: The FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ­>20% as determined by an FDA-approved test. The tablet is the only CDK4/6 inhibitor approved for this indication. The FDA initially approved the drug on Sept. 28, 2017. Recommended dosing for this use is 150 mg twice daily. The monthly list price is $13,058.08.

News Briefs: Oncopeptides AB is withdrawing Pepaxto from the U.S. market | Nov. 16, 2021

Oncopeptides AB is voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company disclosed on Oct. 22. The FDA gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. The company said that the decision follows the Phase III OCEAN study, which “the FDA does not consider…meets the criteria of a confirmatory study.”