Tags : Breakthrough Therapy Designation

Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal

Shots: The FDA’s BT designation is based on safety & efficacy data of ongoing P-II study assessing Danicopan in combination with C5 mAb for patients with paroxysmal nocturnal hemoglobinuria (PNH) who are suboptimal responders to C5 inhibitor monothx. with its expected results in Q4’19  The US FDA’s BT designation expedite the development and review of […]Read More

Roche’s Gazyva (obinutuzumab) Receives FDA’s Breakthrough Therapy Designation for Lupus

Shots: The FDA’s BT designation is based on P-II NOBILITY (NCT02550652) study assessing Gazyva in combination with mycophenolate mofetil/mycophenolic acid and corticosteroids vs PBO + MMF/MPO and corticosteroids in 126 patients with ISN/RPS 2003 class III or IV proliferative lupus nephritis The P-II NOBILITY study resulted in meetings its 1EPs & 2EPs i.e, complete renal […]Read More

Novartis’s Capmatinib (INC280) Receives the US FDA’s Breakthrough Therapy Designation

Shots: The US FDA’s BT designation is based on GEOMETRY mono-1 study involves assessing of Capmatinib and the results were also updated in American Society of Clinical Oncology The BT designation is granted to serious or life-threatening disease therapies demonstrate a substantial improvement over existing therapies on one or more significant preliminary research endpoints Capmatinib […]Read More

Janssen’s Investigational Prophylactic Vaccine Receives the US FDA’s Breakthrough Therapy

Shots: The US FDA’s breakthrough therapy designation is based on the clinical study assessing prophylactic vaccine in RSV patients aged ≥60yrs. vs SOC demonstrating substantial improvement in the clinically significant endpoints Following BT designation, Janssen’s vaccine is eligible for all associated FDA features and is currently being evaluated in P-IIb proof of concept study evaluating […]Read More

AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation

Shots: The BT designation was based on two studies. The P-III ELEVATE-TN (ACE-CL-007) study involves assessing of Calquence as monothx. or in combination with obinutuzumab vs chlorambucil + obinutuzumab in 535 patients in a ratio (1:1:1) with previously untreated CLL The P-III ASCEND (ACE-CL-309) study involves assessing of Calquence (100mg, qd) as monothx. vs rituximab […]Read More

Merck and Eisai’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive FDA’s

Shots: The third BT designation is based on P-Ib KEYNOTE-524 study assessing Keytruda (200mg, IV, q3w) + Lenvima (12/8 mg/day) in patients with unresectable HCC not amenable to locoregional treatment The dual regimen has received its first two BT designation for advanced and metastatic renal carcinoma and non-microsatellite instability-high/proficient mismatch repair endometrial carcinoma in Jan’18 […]Read More

Insights+: Breakthrough Therapy Designation by the US FDA in 2018

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to the drugs as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available therapies […]Read More