FDA Brief: Week of Feb 22, 2016

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GAZYVA (obinutuzumab) Injection

 Genentech, Inc, San Francisco, CA, USA

Indication: In combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen

Reg. Pathway: Supplemental BLA, (previously approved for chronic lymphocytic leukemia), Priority Review

Efficacy:

• Single open-label, multicenter, randomized study (n=321); patients with FL who had no response to or have progressed during or within 6 months of rituximab or a rituximab-containing regimen; GAZYVA plus bendamustine vs. bendamustine alone

• 6 cycles of Gazyva plus bendamustine followed by continued Gazyva monotherapy for up to 2 years with 6 cycles of bendamustine therapy

• Primary Endpoint: Progression Free Survival (PFS) by independent review. Median PFS 13.8 months  for bendamustine alone vs . not reached in the Gazyva plus bendamustine, p-value < 0.0001

• Median Overall Survival not yet reached in either arm

Safety:

• Serious adverse reactions:  Febrile neutropenia, neutropenia, infusion related reactions, sepsis, pneumonia and pyrexia

• Most common adverse reactions:  Infusion reactions, neutropenia, nausea, fatigue, cough, diarrhea, constipation, pyrexia, thrombocytopenia, vomiting, upper respiratory tract infection, decreased appetite, arthralgia, sinusitis, anemia, asthenia and urinary tract infection.

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AFINITOR ( everolimus) Tablet

Novartis, East Hanover, NJ, USA

Indication: Treatment of adult patients with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease

Reg Pathway:  Supplemental NDA (previously approved for breast cancer and several other cancer indications)

Efficacy:

• Single, multicenter, randomized (2:1), n=302,  patients with unresectable, locally advanced or metastatic, well differentiated (low or intermediate grade), non-functional (no current or prior history of carcinoid symptoms), neuroendocrine tumors (NET) of gastrointestinal or lung origin

• Afinitor plus best supportive care (BSC)  vs.  placebo plus BSC

• Primary Endpoint : Improvement in progression-free survival (PFS)

• Median PFS : 11 mo. vs. 3.9 mo., p <0.001

• Overall Response Rates: 2% vs. 1%

• Overall Survival: No statistically significant difference

 

Safety:

• Serious adverse reactions: In  42% of Afinitor-treated patients and included 3 fatal events (cardiac failure, respiratory failure, and septic shock

• Most common adverse reactions: Stomatitis, infections, diarrhea, peripheral edema, fatigue and rash

• Most common laboratory abnormalities: anemia, hypercholesterolemia, lymphopenia, elevated aspartate transaminase and fasting hyperglycemia

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