Hyderabad, India (Press Release) – NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that it has reached a Settlement Agreement with Onyx Thera­peutics, Inc. on patent lit­i­ga­tion related to generic versions of 10mg, 30mg and 60mg of Kyprolis®. NATCO has partnered with Breckenridge Pharma­ceu­tical, Inc., who will mar­ket the prod­uct in the United States.

The parties have reached a Settlement Agreement and the District Court case has been dismissed. By virtue of the settlement, NATCO and Breckenridge have been granted a license permitting the launch of their generic car­filz­o­mib prod­uct …

A team of U.S. researchers has published the results of an in­ves­ti­ga­tion into eyelid-related com­pli­ca­tions in multiple myeloma patients receiving treat­ment with Velcade or Kyprolis. Drawing on the results of their in­ves­ti­ga­tion, the authors of the new study also propose guidelines for the prevention and man­agement of such com­pli­ca­tions.

The authors report on a case series of 16 patients who devel­oped either blepharitis or chalazia after starting treat­ment with Velcade (bor­tez­o­mib) or Kyprolis (car­filz­o­mib).

Blepharitis is the medical term for chronic inflammation of the eyelid, and a chalazion is a cyst in …

Italian researchers have found that common measures of heart and blood vessel health may predict the risk of heart-related side effects in multiple myeloma patients treated with Kyprolis (car­filz­o­mib).

In particular, the researchers found that myeloma patients who ex­peri­enced heart-related side effects while being treated with Kyprolis had sig­nif­i­cantly higher blood pressure, left ventricular mass, and pulse wave velocity before starting Kyprolis treat­ment than patients who did not ex­peri­ence heart-related side effects.

Blood pressure, left ventricular mass, and pulse wave velocity are well estab­lish­ed markers of heart and blood vessel health and …

Calgary, AB and San Diego, CA (Press Release) – Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), cur­rently devel­op­ing pelareorep, an in­tra­venously delivered immuno-oncolytic virus, today announced that the first patient was treated in a phase 1 dose escalation study combining pelareorep and car­filz­o­mib with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo® (nivolumab) to treat re­lapsed multiple myeloma patients. This study is based on findings from the NCI 9603 multiple myeloma study that com­bined pelareorep with car­filz­o­mib that resulted in objective responses, elimination of multiple myeloma cells and most importantly, an inflamed pheno­type with PD-L1 …

The U.S. Food and Drug Admin­istra­tion (FDA) has approved the addi­tion of a once-weekly dosing regi­men to the official pre­scrib­ing in­­for­ma­tion for Kyprolis.

In addi­tion, the FDA approved revisions in the pre­scrib­ing in­­for­ma­tion related to two safety issues: the risk of heart-related side effects due to Kyprolis, and the risk of birth defects or miscarriage in women taking or exposed to Kyprolis during preg­nancy.

The once-weekly dosing of Kyprolis is approved for use in com­bi­na­tion with dexa­meth­a­sone (Decadron) in multiple myeloma patients who have re­lapsed after one to three prior lines of …

• Approval of a More Convenient Once-Weekly Kd70 Regimen Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study
• Application Granted Priority Review Desig­na­tion
• Application Reviewed and Approved Under FDA's Real-Time Oncology Review and Assessment Aid Pilot Programs

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (car­filz­o­mib) to in­clude a once-weekly dosing option in com­bi­na­tion with dexa­meth­a­sone (once-weekly Kd70) for patients with re­lapsed or refractory multiple myeloma. The approval is based on data from the Phase 3 A.R.R.O.W. trial, which dem­onstrated that KYPROLIS admin­istered once-weekly at 70 mg/m² with dexa­meth­a­sone achieved superior pro­gres­sion-free survival (PFS) and over­all …

Filing Based on Data From Phase 3 Head-to-Head A.R.R.O.W. Study

Thousand Oaks, CA (Press Release) - Amgen (NASDAQ : AMGN ) today announced the sub­mission of a supple­mental New Drug Application (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) to expand the Prescribing Information for KYPROLIS® (car­filz­o­mib) to in­clude a once-weekly dosing option in com­bi­na­tion with dexa­meth­a­sone (Kd) for patients with re­lapsed or refractory multiple myeloma. The sNDA is based on data from the Phase 3 A.R.R.O.W. trial, demonstrating KYPROLIS admin­istered once-weekly at 70 mg/m² with dexa­meth­a­sone (once-weekly Kd) achieved superior pro­gres­sion-free survival (PFS) and over­all response rates (ORR), with a com­parable safety profile versus …