After consulting with the U.S. Food and Drug Administration (FDA), AstraZeneca has announced that Imfinzi (durvalumab) — which last year failed a confirmatory Phase 3 trial — will no longer be available in the U.S. for people with locally advanced or metastatic bladder cancer. AstraZeneca has opted to voluntarily withdraw Imfinzi after the therapy’s failure,…
Affimed will team up with Roche to conduct a Phase 1/2a clinical trial investigating its innate cell engager AFM24 — a form of immunotherapy — in combination with Tecentriq (atezolizumab) for the treatment of EGFR-positive solid cancers that progressed despite prior therapies. Under a new collaboration agreement, Affimed will fund and conduct the trial, while…
Understanding the molecular components of odors used by trained dogs to detect prostate cancer could help researchers to develop computers with similar diagnostic accuracy, a new study shows. The study, “Feasibility of integrating canine olfaction with chemical and microbial profiling of urine to detect lethal prostate cancer,” was published in PLOS One. An ongoing need in…
Celsion‘s immunotherapy candidate, GEN-1, has received fast track designation from the U.S. Food and Drug Administration (FDA) for advanced ovarian cancer. This designation helps speed the approval of potential medicines that address unmet medical needs in serious or life-threatening conditions. It grants greater access to FDA input throughout the regulatory process and makes GEN-1 eligible…
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Immunocore‘s tebentafusp (IMCgp100) for HLA-A2 positive, inoperable, or advanced uveal melanoma — a common and difficult-to-treat form of eye cancer — the company announced in a press release. The breakthrough therapy status was awarded after a Phase 3 trial showed that tebentafusp worked…
Prolaris — a genetic test that predicts the aggressiveness of prostate cancer — can accurately identify which men with intermediate- or high-risk disease will benefit from adding androgen deprivation therapy (ADT) to standard radiation therapy, a study shows. This Myriad Genetics’ test was found to be superior to other methods at predicting cancer spread (metastasis) in…
She ROCKS, an organization working for earlier diagnosis and better treatments for ovarian cancer, raised $100,000 through recent virtual luncheon fundraisers to support ongoing research into a potential stem cell-based therapy. Since its inception in 2014, She ROCKS has contributed more than $1 million to support ovarian cancer research underway at the University of North…
A combination of Keytruda (pembrolizumab) and Lenvima (lenvatinib) worked better than standard Sutent (sunitinib) at delaying disease progression and prolonging survival in adults with untreated advanced renal cell carcinoma (RCC) — the most common type of kidney cancer in adults — according to data from a Phase 3 clinical trial. In addition, Lenvima also outperformed…
Enhertu (trastuzumab deruxtecan) has been granted conditional approval in the U.K. for the treatment of adults with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. A conditional approval is given to therapies whose benefit of immediate availability outweighs the risk of having less comprehensive data. Still, regulators require additional…
People with advanced multiple myeloma and diffuse large B-cell lymphoma (DLBCL) will soon be able to access Xpovio (selinexor) outside the U.S. through a managed access program. This program, also known as a named patient program, allows patients and doctors in countries where a medicine is not yet approved or available access to them, provided the medicine…
