Remove clinical prostate-cancer
article thumbnail

AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027: GlobalData

Express Pharma

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca /Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy.

article thumbnail

Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer

LifeProNow

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. Preventing or delaying radiographic progression is an important clinical endpoint in assessing oncologic treatment and is very relevant to patients, their caregivers and their families.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

NICE recommends combination therapy for prostate cancer

European Pharmaceutical Review

The UK’s National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending Lynparza (olaparib) for use as combination therapy with abiraterone and prednisone or prednisolone, for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy.

article thumbnail

First patient dosed in AdvanCell’s phase 1/2 trial for prostate cancer treatment

Pharmafile

AdvanCell has announced that the first patient has been dosed with 212Pb-ADVC001 in its phase 1/2 trial for the PSMA-positive metastatic Castration Resistant Prostate Cancer (mCRPC) treatment.

59
article thumbnail

XTANDI® plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

LifeProNow

0.61; P<0.0001), as assessed by the primary endpoint of metastasis-free survival (MFS), in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR). and Pfizer Inc. Freedland, M.D.,

article thumbnail

Bayer’s Nubeqa™ approved for additional prostate cancer indication in China

LifeProNow

March20,2023: “The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). In 2020, an estimated 1.4

article thumbnail

Pfizer’s XTANDI® plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer

LifeProNow

announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR). and Astellas Pharma Inc.

Dosage 100