Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
Treatment indicated for patients with BRAF V600E-mutant metastatic form of disease. Image Credit: Adobe Stock Images/Tex vector Pfizer revealed that the FDA has approved Braftoni (encorafenib) + Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. Previously, the medication was approved for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. “Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, MD, PhD, chief oncology research and development officer, EVP, Pfizer. “Since its initial FDA approval in 2018, Braftovi + Mektovi combination therapy has helped thousands of people living with BRAF V600E- or V600K-mutant ...
Antibodies and immunotherapies are all the rage in the lung cancer drug market, but older, small molecule drugs can still carve out a healthy niche-and AstraZeneca’s Tagrisso is set to be the leader in that market. That’s according to a new report out by analysts at GlobalData who see more than $7 billion in sales by 2029 for Tagrisso, a small molecule kinase inhibitor. It was first approved in 2015 for certain non-small cell lung cancer (NSCLC) patients with an EGFR mutation, later receiving a first-line green light in 2018 and an adjuvant approval in 2020. Tagrisso is AstraZeneca’s biggest-selling drug, making $5.44 billion in 2022, up 15% in 2021 and more than double its newer oncology drugs Imfinzi, an immunotherapy and PARP inhibitor Lynparza. “In the ever-evolving landscape of oncology, small-molecule drugs are carving a significant niche in lung cancer treatment,” said analysts at GlobalData. “Tagrisso is projected to ...
What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda. Using Keytruda both before and after surgery significantly extended the lives of patients with stage 2 to 3b NSCLC in a phase 3 trial, Merck said Tuesday. The Keytruda regimen was pitted against presurgical chemo alone, while Keytruda recipients also received chemotherapy before surgery. The Keynote-671 trial marks the first time an immunotherapy has shown a statistically significant overall survival benefit for certain patients with early-stage NSCLC, Marjorie Green, M.D., head of late-stage oncology development at Merck Research Laboratories, said in a statement. The positive readout comes right before the FDA is expected to decide—by Monday—on Keytruda’s perioperative use as a continuous neoadjuvant-plus-adjuvant therapy in early-stage NSCLC. The trial previously met its other dual primary endpoint, showing Keytruda could reduce ...
Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
AUS Food and Drug Administration (FDA’s) Oncology Advisory Committee (AdCom) has raised questions about the upcoming decision to grant traditional approval of Amgen’s high-profile KRAS G12C inhibitor Lumakras (sotorasib). Lumakras was granted accelerated approval in May 2021 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations, who had received at least one prior systemic therapy. This approval was based on the CodeBreaK 200 trial (NCT04303780) of sotorasib versus docetaxel. Lumakras generated $285m in sales last year worldwide, according to Amgen’s 2022 annual report to shareholders. The latest AdCom questioned the reliability of the data In the briefing document released by the FDA from the meeting, several features of the Codebreak trial were listed that were inconsistent with a sufficient well-controlled trial. The main issue noted was that too many patients were allowed to swap between the treatment and control arms ...
Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients. The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC. A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker. David Hyman, chief medical officer at Loxo@Lilly, said: “The LIBRETTO-431 trial aims to answer an important question about the selection of initial ...
Amgen has shared positive results from a late-stage study evaluating its KRAS inhibitor, Lumakras (sotorasib), in certain lung cancer patients. The phase 3 CodeBreaK 200 trial compared Lumakras to docetaxel chemotherapy in patients with previously treated, locally advanced and unresectable or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). New data from the trial was presented at the American Society of Clinical Oncology (ASCO) annual meeting. NSCLC represents up to 85% of all lung cancer diagnoses. KRAS G12C is the most common KRAS mutation in NSCLC, Amgen reports, and patients with this mutation whose first-line treatment has failed face limited options. According to data from a post-hoc analysis of CodeBreaK 200, which included NSCLC patients with treated or stable central nervous system (CNS) lesions at baseline, Lumakras was associated with a delayed time to CNS progression and longer CNS progression-free survival (PFS) compared with docetaxel. Additionally, an assessment of CNS tumour shrinkage following ...
After a five and a half month wait, Mirati Therapeutics finally has the answer it’s been waiting for on a lung cancer med called sitravatinib: The therapy did not improve survival in a phase 3 study. Back in December 2022, Mirati said that the SAPPHIRE trial would continue to its final analysis instead of getting an interim readout as planned. The company had hoped to use the early data to support an FDA application for approval in second- and third-line non-small cell lung cancer (NSCLC). Mirati was looking for a 3.5-month overall survival benefit, but, according to a brief update Wednesday afternoon, that measure was not successful at the final analysis. The company is not releasing the data set at this time but promised to do so “at a future date.” Patients who are experiencing clinical benefit may continue on treatment at the discretion of the principal investigators. The failure ...
Lung cancer accounts for more than 20% of cancer deaths in the UK A new UK study has revealed the potential of using artificial intelligence (AI) to help doctors diagnose lung cancer earlier. LIBRA, which was led by researchers from the Royal Marsden NHS Foundation Trust, the Institute of Cancer Research, London, and Imperial College London, used data from the CT scans of nearly 500 patients with large lung nodules – abnormal growths – to develop an AI model. The Royal Marsden Cancer Charity, the National Institute for Health and Care Research, RM Partners and Cancer Research UK also supported the study. To assess how effective the new model was at predicting cancer, the team used a measure called the area under the curve (AUC). An AUC of one would indicate a perfect model, while 0.5 would be expected if the model was randomly guessing. The results, which have ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.