fulvestrant (EGL-5385-C-1701) / Eagle Pharma - LARVOL DELTA

Congratulations @ErikaHamilton9 and Team: Camizestrant,a next-gen oral SERD, v fulvestrant in post-menopausal women with ER+, HER2- ABC (SERENA-2): a multi-dose, open-label, randomised, phase 2 trial - Lancet Oncology @SarahCannonDocs @SCRIOncology

Eagle Pharmaceuticals Announces Positive Type C Meeting with FDA for EA-114, an Estrogen Receptor Antagonist Used in the Treatment of Metastatic Breast Cancer in Post-Menopausal Women (GlobeNewswire) - "Eagle Pharmaceuticals, Inc...announced a positive Type C meeting with the U.S. Food and Drug Administration ('FDA'). Eagle and the FDA agreed on a path forward to advance the clinical development of EA-114, an estrogen receptor antagonist used in the treatment of breast cancer in post-menopausal women....Eagle currently anticipates filing a new drug application ('NDA') for EA-114 in 2024....Eagle has filed a patent application pertaining to EA-114 and anticipates pursuing a robust patent portfolio over time....Eagle intends to provide additional updates on the progress of the EA-114 development program for the sub-populations as discussions with the FDA progress."

FDA event • NDA • Patent • Breast Cancer • Oncology • Solid Tumor

Capivasertib-Fulvestrant: gain in free survival in patients with advanced breast cancer [Google translation] (YouTube) - "In this video, Dr. Hope S. Rugo...comments on updated data from the CAPItello-291 study, which demonstrated that the synergy between capivasertib-fulvestrant confers a gain in free survival of progression in subgroups of the CAPItello-291 study, including in patients with a worse prognosis on fulvestrant alone."

Video

PFS Improvement Seen With Capivasertib/Fulvestrant in HR+/HER2- Breast Cancer (Targeted Oncology) - P3 | N=818 | CAPItello-291 (NCT04305496) | Sponsor: AstraZeneca; "Hope S. Rugo...dicusses the methods, design, and key findings from the phase 3 CAPItello-291 trial (NCT04305496)....According to Rugo, there was a significant improvement in progression-free survival among those treated with the combination of capivasertib plus fulvestrant."

P3 data • Video

Eagle Pharmaceuticals Provides Business Update and Reiterates 2023 Guidance (GlobeNewswire) - "PEMFEXY: Market share of commercial (non-340B) pemetrexed usage in community oncology in the U.S. has grown from 6% to 18% early in the second quarter of 2023. Eagle anticipates continued growth in net sales of PEMFEXY in the remainder of 2023 as compared to 2022....EA-114 Product Candidate (for the treatment of HR+/HER- advanced breast cancer, is intended to be an improved version of Faslodex): The Company had positive results from its EA-114 study and intends to conduct a type C meeting with FDA in August. Additional updates are anticipated in the event FDA and Eagle agree on next steps."

Commercial • FDA event • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

FLEX Trial Breast Cancer: SABCS 2022 Mehran Habibi MD Looking at Gene Mutations (Oncology Tube) - "In conclusion, the FLEX trial demonstrated that the combination therapy of palbociclib and fulvestrant is an effective and safe treatment option for patients with HR+, HER2- advanced breast cancer who have not received prior systemic therapy for advanced disease."

Video

Dr Hamilton on the Potential of RLY-2608 in PI3K-Mutated Breast Cancer (OncLive) - "Erika P. Hamilton, MD...discusses the potential of the PI3K inhibitor RLY-2608 in PI3K-mutated breast cancer. Although the FDA approved the PI3K inhibitor alpelisib (Piqray) in combination with fulvestrant (Faslodex) for patients with estrogen receptor-positive disease in May 2019, the adverse effects (AEs) associated with the combination can make it difficult to administer to some patients, Hamilton explains. Since PI3K is expressed in some normal tissue, treatment with PI3K inhibitors translates to AEs, Hamilton adds."

Video

eFFECTOR Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Enrollment continues in Phase 2b KICKSTART trial in non-small cell lung cancer (NSCLC). Topline data is anticipated to readout in the second half of 2023....Initial signals of activity reported in zotatifin, fulvestrant and abemaciclib cohort (ECBF+A) in ER+ breast cancer; cohort expanded from 7 to 18 patients. Enrollment has now completed in this cohort and ORR data for the full 18 patient cohort is anticipated to be available in the first half of 2023."

P2 data • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Capivasertib and Fulvestrant for Patients with Aromatase Inhibitor-resistant Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer: Results from the Phase III CAPItello-291 Trial (OncLive) - "Hope Rugo, MD reviews key data from the CAPItello-291 phase 3 trial recently presented at the San Antonio Breast Cancer Symposium in December 2022."

Video

ESMO22: Breast cancer research by Sara Tolaney, MD | Dana-Farber Cancer Institute (YouTube) - "Breast Cancer: Results of monarcHER found abemaciclib + trastuzumab +/- fulvestrant was associated w/numerically improved overall survival when compared to chemo + trastuzumab among pts w/HR+, HER2+ advanced breast cancer. Presented at ESMO22."

Video

Recent Updates on CDK4/6 Inhibitors for HR-Positive, HER2-Negative Metastatic Breast Cancer - Episode 14: HR+/HER2- Breast Cancer: Excitement for Upcoming Clinical Trial Readouts (OncLive) - "Richard Finn, MD: In the coming years, [we'll be speaking about]... overall survival data from PALOMA-2....We saw novel therapies in this space, specifically with sacituzumab in ER+ breast cancer, as well as data with HER2 antibody-drug conjugate in HER2-low breast cancer. All these studies have been eagerly awaited."

Video

Puma Biotechnology Announces Publication of Neratinib Abstract Titles for the 2022 ASCO Annual Meeting (Businesswire) - "Puma Biotechnology...announced the release of titles of abstracts on neratinib to be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The ASCO Annual Meeting will be held at McCormick Place in Chicago and online from June 3-7. Posters will be available on Puma’s website following presentation."

P2 data • Breast Cancer • Oncology

A 54-Year-Old Woman with ER+/PR+ Breast Cancer - Episode 6: ER+ Early Breast Cancer Future Directions and A Note on Ki-67 Analyses (Targeted Oncology) - "Lowell Hart, MD, FACP: Well, it is a very exciting time for women [with] both early and advanced hormone receptor-positive breast cancer. From the days of just having tamoxifen and the emergence of the aromatase inhibitors, things have changed greatly. The availability of the CDK4/6 inhibitors has been an amazing breakthrough for many, many women with advanced disease, and I am very excited that now at least 1, and possibly eventually more than 1, may become available for use in the primary care setting, too."

Video

Updates in HR+ HER2- Advanced or Metastatic Breast Cancer - Episode 16: Novel Agents Under Study for HR+/HER2- MBC (OncLive) - "Gabriel Hortobagyi, MD, MACP, FASCO: These are very exciting times and arguably the most exciting times since I’ve been in oncology, which is more than a few weeks. First, an area we haven’t mentioned is that a number of other CDK inhibitors are under development: CDK2, CDK7, CDK9, CDK12....The Breast Cancer Research Foundation is funding a multiproject program to address this issue, to understand the biology of androgen receptor, and to understand the activity of androgen receptor–active agents....This is a very exciting field because the technology gives us the possibility of developing many more of these, having identified many relevant and worthwhile targets."

Video

Advances in Hormone Receptor Positive Metastatic Breast Cancer - Episode 2 First-Line Approaches for HR+ Metastatic Breast Cancer (OncLive) - "Gabriel N. Hortobagyi, MD, FACP: The CDK4/6 inhibitors have been a major addition to our treatment of hormone receptor–positive primary breast cancer. At this point, we select treatments for this group of patients, based essentially on the expression of estrogen and progesterone receptors...We have 3 CDK4/6 inhibitors available in North America and much of the Western world: ribociclib, palbociclib, and abemaciclib....Having said that, some patients will prefer total oral therapy, while others will prefer an intramuscular administration of a drug once a month. It becomes a question more of patient preference than of medical evidence."

Biomarker • Video

Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration (clinicaltrials.gov) - P1; N=600; Completed; Sponsor: Eagle Pharmaceuticals, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

Dr. O'Shaughnessy on the Rationale for the MonarchE Trial in Breast Cancer (OncLive) - "Abemaciclib (Verzenio), a potent CDK4/6 inhibitor has demonstrated a survival advantage in patients with metastatic breast cancer who were previously treated with an aromatase inhibitor (AI) and fulvestrant (Faslodex), says O'Shaughnessy. The agent appears to be particularly beneficial in patients with breast cancer who have virulent disease with poor prognoses. This could include those with short disease-free intervals, liver metastases, grade 3 disease, or progesterone receptor-negative disease, O'Shaughnessy explains."

Video

Alpelisib/Letrozole Retains Efficacy in PIK3CA-Mutant HR+ Advanced Breast Cancer Post-CDK4/6 Inhibition/Fulvestrant (OncLive) - P2, N=1201; BYLieve (NCT03056755); "'Data from these patients, many of whom progressed on a prior AI [aromatase inhibitor], as well as CDK4/6 inhibitors and fulvestrant, suggest that the combination of alpelisib and letrozole maintains efficacy with manageable adverse effects [AEs]. Thus, it may be an effective treatment option for patients with PIK3CA-mutated, HR-positive advanced breast cancer who progress on prior treatment with a CDK4/6 inhibitor and fulvestrant,' Hope S. Rugo, MD...said in a virtual presentation of the data."

Media quote

Eagle Pharmaceuticals Reports Third Quarter 2020 Results (Businesswire) - "Held a positive Type C meeting with FDA on fulvestrant and is in the process of gaining agreement on the details of the formal protocol for the clinical study; Centers for Medicare & Medicaid Services established unique Healthcare Common Procedure Coding System code, or J-code, for PEMFEXY™ (Pemetrexed for Injection, 10 mg), a branded alternative to ALIMTA® effective October 1, 2020."

Clinical • FDA event • Oncology

Eagle Pharmaceuticals advances novel and proprietary formulation of fulvestrant product candidate EA-114; company to request additional meeting with U.S. Food and Drug Administration (“FDA”) (Businesswire) - "Eagle Pharmaceuticals, Inc…provided an update on its pilot clinical study to assess the unique characteristics of its fulvestrant product candidate, EA-114, which has the potential to enhance estrogen receptor ('ER') inhibition and improve patient outcomes…'We have had two meetings with FDA and will request another meeting to discuss these data. With FDA’s guidance, we hope to move ahead with our plans. We look forward to providing additional updates on the progress of this potential drug treatment for hormone-receptor ('HR')-positive advanced breast cancer,' stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals."

FDA event • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Eagle Pharmaceuticals commences dosing in pilot study for novel estrogen receptor antagonist product candidate (Eagle Pharmaceuticals Press Release) - "Eagle Pharmaceuticals, Inc...today announced that the Company has commenced dosing in a pilot clinical study to assess the unique characteristics of its fulvestrant product candidate, which has the potential to enhance estrogen receptor...inhibition and improve patient outcomes. The results of the pilot study will inform the design of the Company’s pivotal trial, which Eagle expects to commence in 2020."

Clinical data • Enrollment open

Eagle Pharmaceuticals announces clinical development plan of innovative product intended to deliver maximum estrogen receptor inhibition in patients with estrogen receptor (ER)-positive breast cancer (Businesswire) - “Eagle Pharmaceuticals, Inc….announced a clinical development plan to support the submission of a New Drug Application (NDA) for the Company’s innovative fulvestrant formulation. Fulvestrant, an estrogen receptor antagonist with no agonist properties, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced hormone-related breast cancers….Eagle intends to begin a pilot study shortly…Depending on recruitment rates and other factors, Eagle believes the pivotal study could be completed within approximately 12 months of commencing enrollment.”

Clinical protocol • Trial status