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CURE’s lung cancer page is an extensive resource of cancer information featuring the latest lung cancer news, expert oncologist insights on the latest cancer treatments, oncology research, advocacy efforts, and medical data on lung cancer.

Last week, the Food and Drug Administration (FDA) approved four different therapies in the oncology space — one of which, Amtagvi, marks the first cellular therapy for the treatment of solid cancers.

Onivyde regimen for metastatic pancreatic cancer

) was covered in last week’s episode, but here’s a list of what has happened since that last recording.

FDA Approves Tepmetko for Metastatic NSCLC Subtype

Patients with metastatic non-small cell lung cancer that has MET exon 14 skipping alterations may soon have a new treatment option, as the FDA approved Tepmetko in this indication.

Notably, this full approval is coming three years after the agency’s accelerated approval of the agent back in February 2021. Follow-up clinical trial data showed that 57% of previously untreated patients responded to therapy with Tepmetko, with 40% having a duration of response that lasted a year or longer.

FDA Approves Amtagvi for Pretreated, Advanced Melanoma

On Feb. 16, the FDA approved Amtagvi for patients with advanced melanoma who had previously been treated with an immunotherapy or targeted therapy. Notably, Amtagvi is a cell-based therapy and is actually the first cell-based treatment to be approved in the solid tumor space.

According to trial results that led to the approval, 31.5% of patients responded to therapy. Now this is a pretty exciting number, considering that this heavily pretreated population tends to have low response rates. Not to mention, TIL therapies like Amtagvi — while upfront they require about a three-week hospital stay — may set patients up for years without having to undergo more treatment, according to Dr. Rodabe Amaria from The University of Texas MD Anderson Cancer Center, who I spoke with after the approval.

Tagrisso Plus Chemo Approved by FDA for EGFR-Mutated NSCLC

In the lung cancer space, we saw the approval of Tagrisso plus platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.

Findings from the FLAURA 2 trial led to this approval, as data showed that progression-free survival was 25.5 months for patients who received Tagrisso plus chemotherapy, compared to 16.7 months for patients who received Tagrisso alone. Overall survival data is still immature at this point — meaning that the researchers just don’t have enough data to calculate averages — so stay tuned for more on that.

For more news on cancer updates, research and education, don’t forget to 

February brought in multiple FDA approvals in the oncology space. Here’s an overview of some of the most recent ones. 

FDA Approvals from February 2024

Last week, we saw a few moving parts in the regulatory space, from new NCCN guidelines for pediatric neuroblastoma treatment to FDA Fast Tracks and Priority Reviews. Also last week, we covered research showing that a lower dose of an anti-emetic drug could have similar efficacy — and fewer side effects — than the standard, higher dose.

NCCN Guidelines Give Framework for Childhood Neuroblastoma Treatment

The National Comprehensive Cancer Network recently published guidelines for the treatment of pediatric patients with neuroblastoma. This resource is geared toward mitigating unnecessary side effects and over treatment in patients with low-risk disease, while also developing the best treatment plans for high-risk patients.

CURE® spoke with Dr. Rochelle Bagatell, professor of Pediatrics and Solid Tumor Section Chief at Children's Hospital of Philadelphia, and Chair of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel for Neuroblastoma, who emphasized that while these guidelines can influence treatment strategies, conversations between patient families and clinicians and even insurance coverage, each patient’s care should be as personalized as possible.

“There may be specific cases where the nuances of a particular patient's case means that you have to adjust your thinking from what's written on those nice, clear lines,” Bagatell said. “But the general guidance about how to think about the risk of recurrence, what general type of therapy would be appropriate, how much chemotherapy when to do surgery. Those are the kinds of things that patients and families can look at and bring to their doctor and discuss.”

FDA Fast Tracks ARV-471 for Metastatic Breast Cancer

Last week the Food and Drug Administration (FDA) granted a Fast Track designation to ARV-471, a novel drug being studied for the treatment of patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. Specifically, this indication of ARV-471 is for patients who previously underwent endocrine therapy.

Fast Track designations are given to drugs that show promise in treating serious conditions and fill an unmet need. The goal is to speed up the review and potential approval of these therapies.

ARV-471 is being studied in the phase 3 VERITAC-2 clinical trial, which is comparing ARV-471 to Faslodex in this patient population. Preclinical studies showed that the drug induced tumor shrinkage and degradation.

FDA Grants Priority Review for Alecensa in Some ALK-Positive NSCLC

Also in FDA news from last week, the agency granted a priority review to Alecensa as a postsurgical treatment for patients with early-stage ALK-positive non-small cell lung cancer.

The priority review is based off findings from the phase 3 ALINA trial, which showed that the drug led to a 76% reduction in the risk of disease recurrence or death compared with chemotherapy treatment. Findings from this study also showed that at two years, 93.8% of patients taking Alecensa experienced disease-free survival (which is the time after treatment when patients do not have symptoms of complications from their cancer), compared with 63% in the chemotherapy group. At three years, disease-free survival rates were 88.3% and 53.3%, respectively.

With the priority review, the FDA said that they plan on making an approval decision on Alecensa on or by May 22, 2023, though those dates can always change.

Lower Dose of Nausea, Vomiting Drug Controls Chemo Symptoms

Finally, research showed that a lower dose of a nausea and vomiting drug could be just as effective as the higher, standard dose when it comes to controlling chemotherapy-induced nausea and vomiting.

 found that a 2.5-milligram dose of olanzapine is not inferior (meaning it is no less effective) than a 10-milligram dose. Specifically, the researchers looked at the use of rescue medications, vomiting episodes and mild nausea over the course of 120 hours.

Notably, this lower dose can also lead to a decrease in side effects related to the drug, such as feeling of lethargy and drowsiness.

Last week, we saw a few moving parts in the regulatory space, from new NCCN guidelines for pediatric neuroblastoma treatment to FDA Fast Tracks and Priority Reviews

Guidelines for Childhood Neuroblastoma, FDA Decisions and More

Last week, we saw some research regarding how a popular tool used to plan breast cancer treatment may be misguiding therapy for Black women, as well as an update on when we can expect to see a new cancer vaccine be readily available for patients.

And on the FDA front, we’ll discuss a priority review for Enhertu for patients with HER2-positive solid cancers, as well as a fast track designation for a new drug duo in the lung cancer space.

Cancer Vaccine Likely ‘Several Years’ Away From Wide Availability

ELI-002 is a vaccine being investigated for the treatment of patients with KRAS-mutant pancreatic or colorectal cancers. While cancer vaccines have been in the headlines a lot in recent months, this one, at least, is still a ways away from being readily available for patients across the United States.

Findings from a phase 1 trial showed that the vaccine could be beneficial for this patient population, and now, a phase 2 trial recently started that will evaluate the efficacy of an injection version of ELI-002, compared to observation. The first patient was dosed in the trial in January 2024, so it could still be several more years until the drug is available, Dr. Christopher Haqq, chief medical officer and vice president, head of research and development at Elicio Therapeutics, said in an interview with CURE®.

“We'll be talking to the regulators like the US Food and Drug Administration and others around the world to align on the data that we'll need to provide for a marketing application. And so, we haven't had that input yet. So I can't give an exact answer for you (on when the vaccine will be commercially available). But we'll work as fast as possible. It's even possible that the type of evidence that we gather in this randomized study could serve that purpose. But we won't know until we have further discussion,” he said.

Test May Be ‘Misguiding’ Breast Cancer Treatment for Black Women

A recent study showed that the 21-gene breast recurrence score may lead clinicians away from prescribing chemotherapy to Black women who may benefit from the treatment.

The 21-gene breast recurrence score is the standard test to help guide treatment decisions for patients with estrogen receptor-positive (also known as ER-positive) disease. Most patients with ER-positive cancer undergo hormone therapy, but the outcomes for this test may help decide if a patient would benefit from additional chemotherapy, too. Now, findings from a recent study discovered that Black women — and younger Black women, in particular — may be missing out on chemotherapy that they could potentially benefit from.

Now, this research team is conducting further research looking at potential molecular differences in breast cancer in Black women, as well as how other social disparities could be playing into an increased risk of breast cancer death in these women.

FDA Grants Priority Review to Enhertu for HER2-Positive Solid Cancers

The Food and Drug Administration granted a priority review for a supplemental biologics license to Enhertu for the treatment of patients with previously treated metastatic HER2-positive solid tumors that cannot be removed via surgery. Basically what that means is that the drug showed promise in a clinical trial, and now the FDA will work with the pharmaceutical company developing the drug to expedite the review and potential approval of the agent. The agency plans on making its decision on whether or not Enertu will be approved some time in the second quarter of this year.

Enertu is an antibody drug conjugate, which is a type of drug that works by finding and binding to certain proteins found on cancer cells — in this case, the HER2 protein. The drug was previously approved for patients with lung cancer and metastatic breast cancer, and now, the phase 2 DESTINY-PanTumo02 trial will help determine if it will be approved for patients with endometrial, cervical, ovarian, bladder, biliary tract, pancreatic or other cancers that are HER2 positive.

FDA Grants Fast Track Designation to Avutometinib-Lumakras Combo

Also in the regulatory space, the FDA granted a fast track designation to a two drug combination consisting of Lumakras and the novel agent, avutometinib for patients with KRAS G12C-mutant metastatic non-small cell lung cancer. The intended patient population for the regimen is those who have been treated with at least one systemic therapy and have not received a KRAS G12C inhibitor.

The regimen is being investigated in the ongoing phase 1/2 RAMP 203 trial, which will analyze the effectiveness of the drug, as well as the overall response rate — which is the percentage of patients whose cancer decreases from the drug — and safety. Findings from the second phase of the trial, which is specifically looking at patients who have not received or did not respond to a KRAS G12-inhibitor are expected to be published some time in the first half of 2024.

One cancer vaccine may still be years away from being available, a breast cancer test may be misguiding treatments for Black women and the review of two oncology regimens are being expedited by the FDA. 

FDA, Cancer Vaccine Updates and a Misguiding of Breast Cancer Treatment

It wasn’t even two weeks into the new year when the Food and Drug Administration made their first FDA approval. In this case, it was a Keytruda regimen for certain patients with gynecologic cancers. We at CURE® spoke with the primary investigator on the study leading to the approval about what patients need to know about the latest new indication.

Also last week, we highlighted the Lymphedema Treatment Act and spoke to an expert about the new law.

Another story in the regulatory space: the FDA granted a Fast Track designation to speed up the review of a novel drug used to treat patients with relapsed or refractory CLL or SLL.

Finally, research from the American Cancer Society showed that Medicaid expansion states tended to have improved post-surgical outcomes in patients with non-small cell lung cancer.

Keytruda Plus CRT Offers ‘Better Chance of Cure’ in Advanced Cervical Cancer


The Food and Drug Administration has granted approval for Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of stages 3 to 4A cervical cancer, marking the first approval of an anti-PD-1 therapy with chemotherapy for this patient population and the third FDA approval for treating cervical cancer with Keytruda.

This week, I spoke with Dr. Linda R. Duska, a gynecologic oncologist and principal investigator on the study leading to the approval, who discussed the KEYNOTE-A18 trial, which enrolled 1,060 patients and demonstrated a 30% decrease in progression for those receiving the combination of Keytruda and chemotherapy. The overall survival data is not yet mature, but the treatment showed a 41% reduction in the risk of disease progression or death. While Dr. Duska emphasized that cervical cancer is preventable thanks to a safe and effective vaccine, she said that for patients with the disease, this new regimen is particularly exciting.

January is also Cervical Cancer Awareness month, so definitely stay tuned to curetoday.com for more of our coverage on the disease.

Medicare Must Now Cover Lymphedema Treatment Garments

The Lymphedema Treatment Act, signed into federal law on Dec. 23, 2022, is now in effect as of Jan. 1, 2024, allowing Medicare coverage for doctor-prescribed compression supplies for patients experiencing. The bill encompasses standard and custom-fitted gradient compression garments and other approved items prescribed by healthcare professionals to treat lymphedema. Now basically what that means is that patients insured by Medicare Part B can now have their lymphedema garments covered by insurance.

This coverage is expected to ease financial burdens on patients, especially as these garments can be expensive.

I spoke with Joanna Fawzy Doran, CEO of Triage Cancer, who emphasized the importance of patient and provider awareness about coverage rights, appealing denials and navigating the process. Although the law does not mandate private insurers to cover compression sleeves for lymphedema patients, Doran noted that Medicare's coverage sets a precedent for broader access in the future.

FDA Grants NX-5948 Fast Track Designation for R/R CLL, SLL

The FDA has granted Fast Track designation to NX-5948, a novel drug, for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously undergone two lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.

Fast Track designation aims to expedite the development and review of drugs addressing serious conditions with unmet medical needs.

NX-5948 is currently in a Phase 1a/1b clinical trial, with initial findings presented at the 2023 American Society of Hematology (ASH) annual meeting indicating safety, tolerance, and clinical activity. The drug showed no dose-limiting toxicities or treatment-related side effects leading to discontinuation, and the most common side effects were purpura/contusion, nausea, and thrombocytopenia.

Medicaid Expansion May Decrease Early Mortality in Some With NSCLC


States with Medicaid expansion tended to have a significant decrease in early, postoperative mortality from non-small cell lung cancer, according to recent research.

The research focused on nearly 15,000 patients undergoing surgery for NSCLC, with 62.1% residing in states supporting Medicaid expansion. The study found notable reductions in 30-day and 90-day postoperative mortality in patients with stages 1, 2, or 3 NSCLC in expansion states. Patients in non-expansion states were found to be younger, non-Hispanic Black, uninsured, and with comorbidities.

The study also evaluated changes in early mortality before and after the Affordable Care Act (ACA) implementation, showing a decrease in the 30-day mortality rate in expansion states from 0.97% to 0.26% after the ACA. Now, advocates, including the American Cancer Society, continue to emphasize the importance of expanding Medicaid eligibility to improve health outcomes.

We take a look at the first FDA approval in the oncology space for 2024, the Lymphedema Treatment Act and more. 

A Chance of Cure for Cervical Cancer, Lymphedema Treatment Act and More

The year 2024 is now underway. After a busy 2023, we’re now looking back at some of the oncology headlines from the new year.

Notably, we have a clinical trial hold for a lung cancer drug, a trial that showed that a CAR-T cell therapy is cost-effective — though far from cheap — for lymphoma treatment, and a novel drug that’s showing promise for the treatment of myelofibrosis.

FDA Places Hold on Trial Evaluating TIL Therapy in NSCLC

The Food and Drug Administration placed a clinical hold on the ongoing IOV-LUN-202 trial, evaluating LN-145 TIL for patients with non-small cell lung cancer. With the clinical hold, new patients will not be able to enroll on the trial, and those who were previously treated will continue to be monitored.

The FDA placed the hold on the trial after the death of a patient. According to the FDA, the agency has the power to request that a trial be stopped, and then the sponsor — that’s the organization or company running the study — can reply via a response letter addressing the concerns. The FDA then has 30 days to respond, and potentially allow for the trial to resume.

Breyanzi Cost Effective As Second-Line R/R DLBCL Treatment

Research published in the journal, Blood Advances, found that the CAR-T cell therapy, Breyanzi, was found to be a promising and cost-effective treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma — also known as DLBCL.

The study found that the incremental cost-effective ratio of the drug was just over $99,000 per quality-adjusted life-year from a health care perspective, and just over $68,000 from a societal perspective. Both these numbers are lower than the assumed social willingness to pay up to $100,000 per quality-adjusted life-year gained, as established by the American Society of Hematology.

While Breyanzi was deemed to be cost effective, CAR-T cell therapies are still far from inexpensive. In fact, the drug cost rose by 9% since its initial approval for DLBCL in 2022. In a CURE® Speaking Out® video series, Lee Greenberger, the chief scientific officer of the Leukemia & Lymphoma Society, expressed concern about the price of these drugs.

“Some of that the government is going to have to pay, some insurance is going to have to pay, but some of it the patients are going to have to pay as well. And the price tags are going to be significant. How are we going to manage that?

The year 2024 is now underway. After a busy 2023, we’re now looking back at some of the oncology headlines from the new year. 

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