Beth Snyder Bulik Senior Editor In Amgen’s new oncology video series, patient Gina calls her colorectal cancer diagnosis “the best worst thing that’s ever happened to me.” She goes on to talk about her Stage IV diagnosis and initial, terminal prognosis four years ago, but also describes her strong family support system and a group created by her husband around a healing star theme. Gina is one of seven “Patient Points of View” in Amgen Oncology’s new YouTube series, debuting today, and an example of the personal, forthright and unscripted perspectives each person offers. The unbranded campaign includes people with non-small cell lung cancer, small cell lung cancer and gastric cancer as well. Amgen’s goal is to “give them the microphone” to tell their stories for self-empowerment, but also for employees and others who can learn from them, said Michelle Carrillo, executive director of advocacy at Amgen. Several of the ...
After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit.Lynparza can now be used in combination with Johnson & Johnson’s Zytiga and a corticosteroid to treat patients with mCRPC whose tumors have BRCA mutations. The approval limits Lynparza’s use in the mCRPC population to about 10% of patients. The FDA’s decision comes after agency staffers and a committee of outside experts argued that the drug only showed a favorable risk-benefit in that population. Results from the phase 3 PROpel trial showed that the combo cut the risk of disease progression or death by 34% compared with solo Zytiga in newly diagnosed mCRPC patients regardless of mutation status. However, the FDA noted a “significant design flaw” with the trial in its briefing documents ahead of the meeting. Specifically, the FDA argued that the study didn’t ...
Tyler Patchen Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity. In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage. The shortages are causing oncologists across the US to ration platinum-based drugs, according to The Cancer Letter. To restore the supply of cisplatin, the FDA is ...
Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
The collaboration aims to develop novel preclinical models with a view to identifying new treatments Almirall – a company which concentrates on medical dermatology – has linked up with the Centre for Genomic Regulation. The collaboration aims to develop novel preclinical models with a view to identifying new treatments for non-melanoma skin cancer (NMSC). The condition poses a considerable health challenge, with basal cell carcinoma and squamous cell carcinoma representing 70% and 25% of NMSC cases, respectively. The partnership – led by Almirall’s investigators Dr Cristina Gutiérrez and Dr Amadeu Gavaldà – will also incorporate CRG group leader and ICREA research professor Luciano Di Croce and his team. In partnership, they will establish experimental models that enable the validation of new therapeutic approaches and therapies for these diseases. The collaboration has emerged following the request for proposals from AlmirallShare – the company’s open innovation platform dedicated to discovering treatments for ...
Bristol Myers Squibb’s Reblozyl could be an effective initial treatment for anemia patients who are suffering from a group of blood cancers called myelodysplastic syndromes (MDS) and are at a relatively lower risk of progression. That’s the conclusion reached by Olatoyosi Odenike, M.D., from the University of Chicago Medical Center, after she reviewed data from the phase 3 COMMANDS trial that are slated to be presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Odenike is an invited ASCO expert and an opinion leader in the MDS field. The COMMANDS trial is the first study in decades that has shown a benefit for a new agent against erythropoiesis-stimulating agents (ESAs) in low- to intermediate-risk MDS, Noah Berkowitz, M.D., Ph.D., senior vice president of hematology development at BMS, said in an interview with Fierce Pharma. If the FDA eventually agrees with Odenike’s finding, Reblozyl could move from behind ...
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 ...
Eli Lilly is throwing more money behind breast cancer drug Verzenio as it prepares to fend off a challenge from Novartis. Having seen growth hit 100% late last year, the Big Pharma has released a TV spot to push the message that Verzenio can help patients make new memories every day. Ads for Verzenio are a frequent sight on TV screens, with the estimated $111.8 million that Lilly spent on spots last year landing the drug in the 10 top most promoted products. Lilly has continued the promotional push in 2023. The “School Play” Verzenio spot was the second most seen pharma TV ad at the 65th Annual Grammy Awards early this year, and Lilly rolled out a fresh video earlier this month. The latest ad opens with a gray-haired Black woman sitting on a sofa looking at a photo album. As the camera zooms in and flips to an over-the-shoulder shot, a voice-over by the woman says ...
AbbVie and Genmab’s blood cancer therapy, Epkinly (epcoritamab-bysp), has been granted accelerated approval by the US Food and Drug Administration (FDA). The authorisation specifically applies to adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of treatment. DLBCL is the most common type of aggressive lymphoma, with approximately 150,000 cases of the disease diagnosed globally each year. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged, the companies said. However, single agent and ready-available or off-the-shelf treatment options are limited. Epkinly, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, is now the first and only T-cell engaging bispecific antibody for this indication. The FDA’s decision was supported by positive results from a phase 1/2 trial, in which Epkinly delivered an overall response rate of 61%, a complete response rate ...
Advanced or metastatic estrogen receptor-positive (ER+) breast cancer is commonly treated with drugs that block the estrogen receptor. However, estrogens that stimulate the receptor can also be effective. Building on their previous studies, researchers at Dartmouth Cancer Center recently concluded a Phase II clinical trial aimed to test the efficacy of alternating between estrogen stimulation and estrogen deprivation in patients with metastatic ER+ breast cancer, and to identify tumor characteristics that predict who might benefit from this strategy. The results, newly published ahead of print in Clinical Cancer Research, support cyclical estrogen/anti-estrogen therapy as a promising strategy to treat advanced/metastatic ER+ breast cancer. The POLLY trial stands for “Phase II study of Pre-emptive oscillation of ER activity levels through alternation of estradiol/anti-estrogen therapies prior to disease progression in ER+/HER2- metastatic or advanced breast cancer.” Among 19 patients enrolled in the trial, 3 (16%) experienced tumor shrinkage during cyclical treatment and ...
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