FDA

NSCLC Boasts Multiple Targeted Therapies, but Many Patients Are Not Benefiting From Them

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 more than 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 agents approved for NSCLC are targeted therapies that are indicated for specific subsets of the disease, and numerous companion diagnostic tests are available to help providers determine the best treatment for a patient.

Oncologists May Prescribe New Neutropenia Agent Over Others in Class, but Therapy Faces Another Challenge

The FDA recently approved the first novel long-acting granulocyte colony-stimulating factor (G-CSF) in more than 20 years. Payers say they are likely to manage the new agent similar to existing ones, but some oncologists have indicated that they are willing to prescribe it in place of other neutropenia agents, according to Zitter Insights. Still, the leader in the space has a unique quality that has allowed it to continue to retain market share, which may prove challenging for the new drug — at least for the time being.

On Sept. 9, the FDA approved Spectrum Pharmaceuticals, Inc.’s Rolvedon (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The company developed the drug with South Korea’s Hanmi Pharmaceutical Co. The recommended dose is 13.2 mg administered subcutaneously once per chemotherapy cycle.

Payers Say They Are Seeing Cost Savings From Shifting to Biosimilars

As FDA approvals of biosimilars continue and agents expand into new indications, more payers are using these drugs and seeing cost savings through that utilization, according to Zitter Insights.

When the FDA approved Fresenius Kabi’s Stimufend (pegfilgrastim-fpgk) on Sept. 1, it was the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency had approved. It also was the 38th biosimilar approved since the first one, Novartis Pharmaceutical Corp. division Sandoz Inc.’s Zarxio (filgrastim-sndz), was approved March 6, 2015, referencing Amgen’s Neupogen (filgrastim).

News Briefs: Pharma Execs Say Medicare Negotiation Will Dent Profits

Elevance Health, Inc. said on Nov. 9 that it has struck a deal with CarepathRx, a portfolio company of the private equity firm Nautic Partners, to acquire the specialty pharmacy BioPlus. The acquisition “helps us deliver on our whole-health strategy that gives our consumers improved access and reliability to their prescriptions when they need it most,” said Pete Haytaian, executive vice president of Elevance Health and president of its Carelon health services business. Elevance plans to “expand BioPlus’ speed and service models across more complex disease treatment areas to provide timely access to medication, deliver leading support services for both providers and patients, and ensure individuals receive distinctive clinical expertise and service at all levels of care,” it said in a press release. Given that BioPlus currently operates Centers of Excellence addressing therapeutic areas like oncology and multiple sclerosis, Elevance aims to “build out additional COEs” for other therapeutic areas once the specialty pharmacy becomes part of Elevance’s PBM, IngenioRx. The acquisition is subject to customary closing conditions and is expected to close in the first half of 2023.

New FDA Approvals: FDA Grants Additional Indication to Rinvoq

Oct. 21: The FDA granted another indication to AbbVie Inc.’s Rinvoq (upadacitinib) for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors. The agency first approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. Dosing of the extended-release tablets for the newest indication is 15 mg once daily. The wholesale acquisition cost (WAC) of a 30-day supply is $5,671.26.

Oct. 21: The FDA approved AstraZeneca’s Imjudo (tremelimumab-actl) in combination with the company’s Imfinzi (durvalumab) for the treatment of adults with unresectable hepatocellular carcinoma. Dosing for people weighing at least 30 kg is 300 mg of Imjudo, a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, via intravenous infusion plus 1,500 mg of Imfinzi, a programmed death-ligand 1 (PD-L1) inhibitor, also via intravenous infusion at cycle one/day and then Imfinzi as a single agent every four weeks. For those weighing less than 30 kg, dosing is 4 mg/kg of Imjudo plus 20 mg/kg of Imfinzi at cycle one/day one and then Imfinzi every four weeks.

PARP Inhibitors’ Data on Later Line Use in Ovarian Cancer Prompts Indication Withdrawals

Since June, manufacturers of the three FDA-approved poly (ADP-ribose) polymerase (PARP) inhibitors have withdrawn their indications in the later line treatment setting for ovarian cancer. Payers should be reviewing their utilization management criteria to make sure they are covering the drugs in the appropriate setting, advises one industry expert.

In a Form 8-K filed with the U.S. Securities and Exchange Commission on June 16, Clovis Oncology, Inc. said it was voluntarily withdrawing the FDA approval for Rubraca (rucaparib) for the treatment of BRCA-mutated ovarian cancer after at least two chemotherapies based on overall survival (OS) data from the ARIEL4 clinical trial. The company also disclosed that it had requested withdrawal of that indication in Europe. The drug’s indications for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and for the treatment of adults with a deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy, the latter of which has accelerated approval, remain on its label.

Biosimilars Are Picking Up Market Share, but Some Uncertainties Still Exist

Since the FDA’s approval of the first biosimilar — Zarxio (filgrastim-sndz) from Sandoz, a division of Novartis Pharmaceuticals Corp. — on March 6, 2015, the agency has approved almost 40 more agents via the 351(k) pathway established under the Biologics Price Competition and Innovation Act (BPCIA), itself part of the Affordable Care Act (ACA). Although not all of those agents have launched yet, and almost all of the ones that have are all professionally administered, industry experts say they expect to see more competition in the space, depending on interchangeability status, provider uptake and the impact of the Inflation Reduction Act.

Cell and Gene Therapies Hold Promise, but Stakeholders Must Overcome Challenges to Meet Their Full Potential

Researchers continue to make progress in developing cell and gene therapies that offer the promise of slowing a disease’s progression and even offering a potential cure to patients. And while these agents may offer hope to patients, some challenges exist, including access to the treatments. In order for these products to reach their full potential, stakeholders must work together to overcome these potential barriers.

With its Feb. 28 FDA approval, the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc.’s Carvykti (ciltacabtagene autoleucel or cilta-cel) became the sixth chimeric antigen receptor T-cell (CAR-T) therapy approved in the U.S. In addition, the existing CAR-Ts continue to get additional FDA-approved indications added to their labels, including for use in earlier line settings. And in August and September alone, the FDA approved two bluebird bio, Inc. gene therapies: Zynteglo (betibeglogene autotemcel or beti-cel) and Skysona (elivaldogene autotemcel or eli-cel).

News Briefs: Plans, PBMs Are Blocking Access to Birth Control

A congressional panel found that major PBMs and health insurers are charging members cost sharing and imposing other coverage requirements on birth control products in violation of the Affordable Care Act. The “investigation identified more than 30 birth control products for which most health insurers and PBMs reviewed impose cost-sharing requirements or coverage exclusions,” according to a press release. Among the companies examined were CVS Health Corp., UnitedHealth Group, Elevance Health Inc., Cigna Corp., Humana Inc. and Prime Therapeutics, a PBM owned by a consortium of Blues affiliates. “From 2015 to 2021, companies denied exceptions requests on average four or more times out of ten,” the press release added.

Oncologists May Prescribe New Neutropenia Agent Over Others in Class

The FDA recently approved the first novel long-acting granulocyte colony-stimulating factor (G-CSF) in more than 20 years. Payers say they are likely to manage the new agent similar to existing ones, but oncologists have indicated that they are willing to prescribe it in place of other neutropenia agents, according to Zitter Insights.

On Sept. 9, the FDA approved Spectrum Pharmaceuticals, Inc.’s Rolvedon (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The company developed the drug with South Korea’s Hanmi Pharmaceutical Co. The recommended dose is 13.2 mg administered subcutaneously once per chemotherapy cycle. The company says it expects the product to be available in fourth-quarter 2022. It has not revealed the agent’s price yet.