Oncology

New Organization Will Focus on Medical Benefit Drugs

A group of Blue Cross and Blue Shield-affiliated companies recently unveiled a new medication contracting organization focused on medical benefit drugs. The new company, known as Synergie Medication Collective, will be successful in improving the affordability of these treatments and patients’ access to them, an industry expert says, but it also will need to show that patients are seeing those savings.

Unveiled Jan. 5, the company says it “is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans.” It will focus not only on infusible treatments for conditions such as cancer but also on multimillion dollar gene therapies. The company says its goal is to “significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders.” It plans to “bring to market several new product offerings” this year, among them “transformative value-based models.”

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New FDA Approvals: FDA Gives Accelerated Approval to Mirati’s Krazati

Dec. 12: The FDA gave accelerated approval to Mirati Therapeutics, Inc.’s Krazati (adagrasib) for the treatment of adults with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test (see below brief), who have received at least one systemic therapy. Dosing for the tablet is 600 mg twice daily. The drug is priced at $19,750 per month.

Dec. 12: The FDA approved two companion diagnostics for Krazati (see above brief): Agilent Technologies Inc.’s Agilent Resolution ctDx FIRST assay and Qiagen N.V.’s Qiagen therascreen KRAS RGQ PCR kit. A liquid biopsy next-generation sequencing assay, the Agilent test detects genomic alterations in circulating tumor DNA from plasma. The Qiagen test, first approved July 6, 2012, is a tissue-based assay.

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FDA Approved Four New Gene Therapies, Other Novel Agents in 2022

While the FDA may not have approved the most drugs in a year in 2022, it still gave the green light to a number of agents, many of them specialty medications, as well as granted additional indications to existing therapies. The FDA’s Center for Drug Evaluation and Research (CDER) approved 39 new molecular entities in 2022, and the Center for Biologics Evaluation and Research (CBER) approved 12 biologic license applications, including four new gene therapies in the second half of the year. AIS Health, a division of MMIT, asked some industry sources what the most notable 2022 FDA approvals were and why they were so important.

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New Organization Will Focus on Medical Benefit Drugs

A group of Blue Cross and Blue Shield-affiliated companies recently unveiled a new medication contracting organization focused on medical benefit drugs. The new company, known as Synergie Medication Collective, will be successful in improving the affordability of these treatments and patients’ access to them, an industry expert says, but it also will need to show that patients are seeing those savings.

Unveiled Jan. 5, the company says it “is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans.” It will focus not only on infusible treatments for conditions such as cancer but also on multimillion dollar gene therapies. The company says its goal is to “significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders.” It plans to “bring to market several new product offerings” this year, among them “transformative value-based models.”

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News Briefs: FDA Requests Withdrawal of Pepaxto Marketing Authorization

The FDA has requested that Oncopeptides AB withdraw the U.S. marketing authorization for Pepaxto (melphalan flufenamide), the company revealed on Dec. 7. “We respect FDA´s accelerated approval regulations,” said CEO Jakob Lindberg in a statement. The FDA initially 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. But then on Oct. 22, 2021, the company requested voluntary withdrawal of the peptide-drug conjugate’s New Drug Application (NDA). That was followed early in 2022 by Oncopeptides’ rescinding the letter requesting the NDA’s withdrawal based on “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials.” On Sept. 22, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) held a meeting to assess the drug’s risk/benefit profile; it voted 14-2 that the drug is not favorable for adults with relapsed or refractory multiple myeloma. Oncopeptides is commercializing the therapy in Europe, where it is known as Pepaxti, following its full approval on Aug. 18, 2022.

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2022 Saw Continued Approvals, Uptake of Biosimilars

Following the FDA’s March 6, 2015, approval of the first biosimilar in the United States — Zarxio (filgrastim-sndz) from Novartis Pharmaceuticals Corp.’s Sandoz unit — these agents have continued to gain market share, even though not all that have been approved have launched. And while the European Union approved its first biosimilar, Sandoz’s Omnitrope (somatropin), almost a decade earlier on April 12, 2006, the U.S. outpaced the EU in biosimilar approvals in the eight-year post-launch period 40 to 15. Last year continued the trend, with the FDA approving seven new biosimilars. AIS Health, a division of MMIT, asked some industry experts about the agents’ impact over the past year.

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More Cancer Indications With Accelerated Approval Are Being Withdrawn

Three more oncology indications given accelerated approval are being withdrawn from the U.S. market at the request of the FDA. Those mark just shy of 20 oncology indications and/or drugs that have been approved through that accelerated pathway and then subsequently retracted since 2020. While accelerated approval may be benefiting patients with nononcology indications, its track record for oncolytics is not quite as impressive, says one industry expert.

Most recently, Roche said on Nov. 29 that it was voluntarily withdrawing Tecentriq’s (atezolizumab) indication for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express programmed death-ligand 1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The agency granted accelerated approval for that indication on April 17, 2017, to Roche’s Genentech USA, Inc. subsidiary.

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Study Shows Only About One-Third of People With NSCLC Are Benefiting From Appropriate Care

The FDA has approved around 100 targeted therapies for different types of cancer, with many more in the pipeline. Current agents for non-small cell lung cancer (NSCLC), for example, target about 10 different biomarkers, and more than 70% of people with the condition have alterations in their tumors that are tied to available treatments. But a recent study found that due to practice gaps in the precision oncology pathway, just more than one-third of patients with biomarkers that could be treated with an FDA-approved therapy are actually benefiting from those drugs.

Lung cancer is one of the most common types of cancer, and NSCLC makes up the bulk of the cases. Many of the more than two dozen agents approved for NSCLC are targeted therapies that are indicated for specific subsets of the disease, and numerous tests are available to help providers determine the best treatment for a patient.

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New FDA Approvals: FDA Issues Emergency Use Authorization to Kineret

Nov. 9: The FDA issued an emergency use authorization to Amgen Inc.’s Kineret (anakinra) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). The agency initially approved the interleukin-1 receptor antagonist (IL-1Ra) on Nov. 14, 2001. The recommended dosing for this latest use is 100 mg administered daily by subcutaneous injection for 10 days. Drugs.com lists the price of one 100 mg prefilled syringe as more than $1,265.

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More Cancer Indications With Accelerated Approval Are Being Withdrawn

Three more oncology indications given accelerated approval are being withdrawn from the U.S. market at the request of the FDA. Those mark just shy of 20 oncology indications and/or drugs that have been approved through that accelerated pathway and then subsequently retracted since 2020. While accelerated approval may be benefiting patients with nononcology indications, its track record for oncolytics is not quite as impressive, says one industry expert.

Most recently, Roche said on Nov. 29 that it was voluntarily withdrawing Tecentriq’s (atezolizumab) indication for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express programmed death-ligand 1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The agency granted accelerated approval for that indication on April 17, 2017, to Roche’s Genentech USA, Inc. subsidiary.

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