Expanded Access Listings

Novartis

EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

This study will provide pre-approval drug access to lapatinib, in combination withcapecitabine, to patients whose breast cancer had progressed on other therapies

Genentech, Inc.

An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dosecombination formulation for subcutaneous injection (PH FDC SC) administered at home by ahome health nursing provider for patients with human epidermal growth factor receptor2-positive (HER2+) breast cancer who have completed concurrent chemotherapy withpertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV)and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDCSC, or trastuzumab SC in the clinic. The main objective is to enable continuity of careduring the COVID-19 pandemic.This study will enroll approximately 200 patients in the United States.Participants with early or metastatic HER2+ breast cancer will be enrolled in this study.Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks andcontinue treatment unless early cessation is necessary due to disease recurrence, diseaseprogression, unacceptable toxicity, participant withdrawal of consent, or per physician'srecommendation. Participants with early HER2+ breast cancer will receive PH FDC SC tocomplete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, ortrastuzumab SC they received prior to enrolling in this study, unless early cessation isnecessary due to disease recurrence, disease progression, unacceptable toxicity,participant withdrawal of consent, or per physician's recommendation.A remote cardiac surveillance substudy will be optional for patients enrolled at selectsites.The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer arisk for this patient population.

Eli Lilly and Company

Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

The treating physician/investigator contacts Lilly when, based on their medical opinion,a patient meets the criteria for inclusion in the expanded access program.

Mentor Worldwide, LLC

Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis

Mentor is undertaking a five-year prospective clinical study designed to collect safetydata associated with the implantation of its gel-filled mammary prostheses. This study isan "adjunct" study, which will encompass clinical reviews of reconstructive cases in allpatients who meet clinical and regulatory criteria for breast reconstruction withgel-filled mammary prostheses. This "adjunct" study will be accomplished under a limitedclinical protocol in which specific parameters will be required but with controlssomewhat less stringent than those normally required in Investigational Device Exemption(IDE) Trials.

Atossa Genetics

Lantern Pharma

Erytech

Alexion Pharmaceuticals, Inc.

The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

The primary objective is to provide access to eculizumab for PNH patient pendingcommercial availability.

Intensity Therapeutics, Inc.

CytoDyn, Inc.