Strosberg Discusses Lutathera Approval, Remaining Challenges in NETs

Excerpt:

“Findings from the phase III NETTER-1 trial led to the January 2018 FDA approval of Lutathera (lutetium Lu 177 dotatate) for the treatment of patients with somatostatin receptor–positive gastroenteropancreatic tumors (GEP-NETs). The trial compared Lutathera with high-dose octreotide LAR for patients with 1 or 2 metastatic midgut NETs.

“In NETTER-1, patients with midgut NETs who progressed on 30 mg of octreotide were randomized to Lutathera (n = 116) or high-dose octreotide (n = 113). Patients received 4 doses of Lutathera at 7.4 GBq every 8 weeks in combination with 30 mg of octreotide. The control arm received 60 mg of octreotide LAR every 4 weeks.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


Lilly Breast Cancer Treatment Lands Another Approval

Excerpt:

“The U.S. Food and Drug Administration has given another approval for a breast cancer treatment developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The announcement marks the third FDA approval for Verzenio in five months.

“The most recent ruling approves Verzenio, also known as abemaciclib, for use in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of postmenopausal women with advanced or metastatic breast cancer. Lilly says the approval follows the results of a successful Phase 3 clinical trial.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Expands Approval of Imfinzi to Reduce the Risk of Non-Small Cell Lung Cancer Progressing

Excerpt:

“The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Approves New Treatment for a Certain Type of Prostate Cancer Using Novel Clinical Trial Endpoint

Excerpt:

“The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Grants Priority Review to Lorlatinib in ALK-Positive NSCLC

Excerpt:

“On February 12, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to Pfizer’s new drug application for lorlatinib. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2018.

“Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors. It has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of both ALK and ROS1. Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


ZYTIGA® (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer

Excerpt:

“The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for ZYTIGA® (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). The approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk CSPC, ZYTIGA® in combination with prednisone reduced the risk of death by 38 percent compared to placebos.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


Afatinib Approval for Lung Cancer Expanded by FDA

Excerpt:

“The frontline indication for afatinib (Gilotrif) has been expanded by the FDA to include the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor uncommon EGFR alterations in L861Q, G719X, and/or S768I.

“The FDA initially approved afatinib in 2013 for the treatment of patients with metastatic NSCLC with exon 19 deletions or exon 21 L858R substitutions. In 2016, the FDA expanded the indication to include patients with squamous histology following progression on a platinum-based chemotherapy.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


US Awards Novartis’ Kisqali ‘Breakthrough’ Status

Excerpt:

“Novartis’ CDK4/6 inhibitor Kisqali has picked up Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer.

“The US Food and Drug Administration has awarded the designation for of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Approves Stereotactic Radiotherapy System for Breast Cancer

Excerpt:

“The FDA has approved a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod as a treatment for patients with early breast cancer, based on findings from a 17-patient study.

“In the small clinical trial, GammaPod was effectively used to deliver a single “boost” radiation dose of 8 Gy directly to the tumor, while only eliciting grade 1 adverse events (AEs). The system uses a vacuum-assisted breast cup guided by a CT simulator with 1 mm slice thickness to immobilize the breast, which ensures the accurate delivery of radiation to the tumor.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.