The US Food and Drug Administration (FDA) has granted Roche accelerated approval for Columvi, its antibody-based therapeutics for two aggressive forms of lymphoma. Results from a phase 1/2 study found the drug provided durable remission for over half of patients and a complete response for 43%, with 66% continuing to respond for 9 months or longer.
Amgen’s supplemental biologics license application (sBLA) for its leukemia treatment Blincyto has received full approval by the US Food and Drug Administration (FDA). The move comes based on new data from two phase 3 trials, upgrading the treatment’s accelerated approval to a full approval in the treatment of CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL).
In a new interview with AJMC, Courtney DiNardo, MD, MSCE, of the University of Texas MD Anderson Cancer Center detailed how FDA fast track designation can help with the drug development process. She argues that it can help guide trial development in ways that align with agency preferences and priorities. In addition, she spoke about patient recruitment and retention.
A real-world data (RWD) study published in JAMA Oncology finds that administering immunotherapy to patients with advanced non-small cell lung cancer (NSCLC) is appropriate. The study, which followed 1091 patients at Penn Medicine’s Abramson Cancer Center, found that patients whose cancer hasn’t progressed after two years of immunotherapy did not gain any clinical benefits by prolonging treatment past a 2-year period.
Molecular Templates’ clinical trial for MT-0169, its experimental multiple myeloma therapeutic, is back on, following the US Food and Drug Administration (FDA) lifting a partial hold. The hold was placed on the trial following two adverse events experienced by patients, who both recovered. The move comes after the company laid off half its employees to focus on this drug, along with two others.
Real-world data (RWD) to be presented at this year’s upcoming American Society of Clinical Oncology’s Annual Meeting shows that comprehensive genomic profiling (CGP) improves cancer patients’ outcomes. The study, which covered 1,423 advanced cancer patients who received CGP from 2019 to 2021, showed that CGP was associated with improved survival.
In a new Targeted Oncology Case-Based Roundtable, clinicians discussed new real-world data (RWD) supporting the use of durvalumab in unresectable stage III non-small cell lung cancer (NSCLC). The clinicians discussed their use of the immunotherapy, noting that most of them continued the treatment for 12 months, the length of treatment used in the observational study.
Researchers at Korea’s National Cancer Center have released new real-world data (RWD) supporting the use of Yuhan Corp’s Leclaza (lazertinib) in the treatment of a subset of non-small cell lung cancer (NSCLC). The study, basefd on data from 103 patients who used Leclaza as a second-line treatment, showed that the drug improved median progression-free survival (mPFS) out to 13.9 months, an improvement on the 11.1 months mPFS demonstrated in a randomized clinical trial.
A bipartisan group of US House representatives is calling on the Food and Drug Administration (FDA) to address ongoing shortages of key chemotherapy drugs. In a letter written by Debbie Dingell (D-MI) and Tim Wahlberg (R-MI), lawmakers highlight the current shortages of cisplatin and carboplatin and point out they were either caused or exacerbated by a manufacturing hold last year on Intas Pharmaceuticals over quality issues.
The Max Foundation, a Seattle-based organization dedicated to health equity, is collaborating with the biotech BioGene to provide Brukinsa to patients with chronic lymphocytic leukemia (CLL) in 29 lower- and middle-income countries (LMICs). The program will last for 3 years and will also provide education on disease management and diagnosis at participating treatment sites.
ImmunityBio took a loss today after receiving news its marketing application for its bladder cancer drug Anktiva was rejected by the US Food and Drug Administration (FDA). The decision came primarily because of issues with manufacturing facilities. The agency also wants more safety data and information on the duration of treatment response.
A real-world data study presented at this year’s ISPOR meeting showed that biomarker testing for early-stage non-small cell lung cancer (NSCLC) increased steadily over the past ten years. Data from over one thousand patients with early-stage NSCLC from 2011 to 2021, finding that 74.1% of patients had biomarker testing performed within the first six months after being diagnosed with the disease.
A newly published real-world data (RWD) study in Breast Cancer: Targets and Therapy takes a look at the clinical factors and sociodemographics of patients with HER2-low and HER2-zero triple-negative breast cancer at the Brazilian National Cancer Institute. Analysis shows that that there were no significant differences between the two groups in terms of sociodemographic traits, survival outcomes, and clinical behavior.
An artificial intelligence (AI) model developed by UK researchers identified abnormal lung growths that would later become cancerous with a high degree of accuracy. The AI model was developed in the LIBRA study using lung imaging data from 500 patients with large abonormal lung nodules. 82% of the tumors the AI model identified as high-risk were later found to be cancerous.
A recently published article in JAMA Oncology finds that cancer clinics that are smaller or in rural areas are less likely to use immunotherapy for their patients compared to larger clinics and those in urban and suburban areas. The study, based on Medicare claims data taken from 1700 cancer clinics, also showed that the majority of practices implemented new immunotherapies within 2 years of their approval by the US Food and Drug Administration (FDA).
AstraZeneca and Merck’s Lynparza looks set for a narrow approval as part of a combination therapy for metastatic castration-resistant prostate cancer (mCRPC). In an 11 to 1 vote, a Food and Drug Administration (FDA) panel supported approval of the drug in combination with a corticosteroid and J&J’s Zytiga only for a small subset of mCRPC patients.
The UK’s National Institute of Health and Care Excellence (NICE) has issued its approval of J&J and Abbvie’s combination therapy of Imbruvica and Venclyxto for use as a first-line treatment of chronic lymphocytic leukemia (CLL). The combo will be released as a pill taken once per day, the first of its kind for a CLL chemotherapy drug.
Roche has scored a win with the US Food and Drug Administration’s (FDA’s) approval of its drug Polivy for front-line diffuse large B-cell lymphoma (DLBCL). The approval comes after some reviewers were concerned about the benefits of the drug over the standard of care based on results from the phase III POLARIX study.
Shortly after a recommendation from the UK’s National Institute for Care and Health Excellence (NICE), the NHS agreed to provide Lynparza, Merck and AstraZeneca’s prostate and breast cancer drug, to patients in Wales and England. The move comes after positive results showing the drug lowered mortality in breast cancer patients by a third.
In a new draft guidance, the UK’s National Institute for Health and Care Excellence (NICE) decided against recommending Ipsen’s small molecule drug Cabometyx (cabozantinib) for the treatment of differentiated thyroid cancer (DTC). The recommendation comes after approval for the indication was made last year.
After a recommendation from the UK’s National Institute for Health and Care Excellence (NICE), England’s Cancer Drugs Fund (CDF) announced it will cover Merck’s (MSD in the UK) Keytruda for patients living with advanced metastatic cervical cancer. This opens up a new avenue of treatment for the thousands of women diagnosed with the disease in England each year.
In a new draft guidance, the US FDA proposes two strategies to make clinical trials for cancer drugs better support accelerated approval applications for cancer drugs. Such applications are expected to be followed by confirmatory studies that often don’t materialize or yield negative results. The first suggestion is to move to a single trial for accelerated approval that also confirms potential health benefits.
Real-world evidence (RWE) presented at the 2023 Transplantation and Cellular Therapy Meeting compared and contrasted outcomes for patients receiving inpatient vs. outpatient CAR T-cell therapy for mantle cell lymphoma (MCL) and follicular lymphoma (FL). Patients with FL fared better with outpatient treatment, but those fighting MCL had slightly more adverse events (AEs) with outpatient infusions.
Incyte notched a win today, March 23rd, with accelerated approval for retifanlimab, its treatment for a rare, aggressive skin cancer called Merkel cell carcinoma. The approval comes after patients single-arm study achieved a 52% response rate, with 18% seeing a complete response. These responses were durable out to almost 25 months in some patients.
Precision therapy for non-small cell lung cancer (NSCLC) could save patients’ lives, but access to these treatments and the required genomic and biomarker testing are out of reach for many. In a new OncLive interview, Ashling Wahner talks about recently presented research into the impact of targeted therapy, or the lack thereof, with the VP of Science Policy at the Personalized Medicine Coalition Daryl Pritchard, PhD.