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Spectrum Pharmaceuticals, Inc.

Partner : Allergan, Inc.

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FDA Advisory Committee Votes that Qapzola™ (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo
The FDA is Expected to Make a Final Decision by PDUFA Date of December 11, 2016

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that Qapzola for immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) has not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer (NMIBC).

The committee recommendation is not binding on the FDA, which makes the final decision on approval. The Prescription Drug User Fee Act (PDUFA) date for the Qapzola NDA is December 11, 2016.
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Source: press release, 9/14/16. http://investor.sppirx.com/releasedetail.cfm?ReleaseID=989123

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Apaziquone, a potent tumor-activated drug being investigated for non-muscle invasive bladder cancer: The FDA accepted the NDA and has given Spectrum a PDUFA date of December 11, 2016. The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA. The Company is actively enrolling an additional randomized, placebo-controlled Phase 3 trial under an SPA agreement. The Phase 3 study has been specifically designed to build on learnings from the previous studies, as well as recommendations from the FDA.
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Source: press release, 5/05/16. http://investor.sppirx.com/releasedetail.cfm?ReleaseID=969507

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Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for EOquin® (apaziquone for intravesical instillation)

HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced that the U.S. Food and Drug Administration (the "FDA") has accepted the EOquin® (apaziquone for intravesical instillation) New Drug Application (NDA) for review. The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of December 11, 2016.
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Source: press release, 2/19/16. http://investor.sppirx.com/releasedetail.cfm?ReleaseID=955781

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Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Upcoming Apaziquone Phase 3 Trial in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)
Company is on Track for Apaziquone NDA Filing by Year End Based on Pooled Data from Two Completed Phase 3 Studies that Showed a Statistically Significant Reduction in 2-Year Recurrence Rates (p-value = 0.0218)
Learnings From Earlier Phase 3 Program and FDA's Comments Incorporated in New Phase 3 Study Design
New Phase 3 Study Would Satisfy FDA's Requirement of Initiating an Additional Phase 3 Study Before Apaziquone NDA Submission
NMIBC is the Fifth Most Common Cancer in the U.S. With Highest Per Patient Cost and High Unmet Medical Need Due to High Recurrence Rates and No FDA-approved Agents
HENDERSON, Nev.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in Hematology and Oncology, announced today that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) of the planned Phase 3 clinical trial of its novel, potent pro-drug, apaziquone. This trial will further evaluate the intravesical use of apaziquone for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) as one or two instillations, immediately following transurethral resection of bladder tumor (TURBT).

"Spectrum's agreement with the FDA on the SPA represents a significant milestone for bladder cancer patients," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The learnings from previous Phase 3 studies and comments from the FDA have been incorporated in the new protocol to improve the chances of success. We look forward to initiating this trial and filing the apaziquone NDA by year-end. This NDA is based on data from the previously completed program that included two Phase 3 studies with a total of 1,615 patients. We believe there continues to be a significant unmet need for these patients, as no drugs have been approved in the U.S. for more than 40 years for the treatment of low-grade NMIBC. Due to the high rate of recurrence, the overall cost of the treatment of bladder cancer in the U.S. is a staggering $3.4 billion annually, most of which is related to direct treatment of the disease. We endeavor to bring this much needed therapy for patients and help reduce overall medical costs at the same time."

In accordance with the SPA, the Phase 3 trial will be a randomized, double-blind, placebo-controlled, multicenter trial that will enroll patients with Ta G1 or G2 NMIBC. The patients will be randomized to receive either one instillation of apaziquone, two instillations of apaziquone, or placebo. The primary endpoint is Time to Recurrence. Since apaziquone is known to be inactivated in presence of blood, the new protocol includes a 30-60 minute waiting period post-TURBT, before apaziquone instillation. Patients that receive two instillations of apaziquone, will receive the second dose approximately two weeks after surgery minimizing the potential for drug inactivation due to bleeding. Further, it is recommended that patients with significant post-operative bleeding not receive apaziquone.

Apaziquone is an anticancer pro-drug that is activated by bio-reductive enzymes that are over-expressed in bladder cancer cells, rendering it into a highly cytotoxic alkylating agent. Spectrum has conducted two multi-center, international Phase 3 trials of a single intravesical instillation of apaziquone (4 mg) into the bladder in the immediate post-operative period after surgical resection of low-grade NMIBC. Pooled data from the two studies (n=1,615) showed a statistically significant treatment effect for the primary study endpoint, 2-Year Recurrence Rates, in favor of apaziquone (p-value = 0.0218) and in a key secondary endpoint, Time to Recurrence (p-value = 0.0096).
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Source: press release, 8/17/15. http://investor.sppirx.com/releasedetail.cfm?ReleaseID=927827

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Ken Keller, EVP, Chief Operating Officer, commented on upcoming milestones. He stated, "We expect 2014 to be an active and productive year, marked by a number of key value-creating milestones. Number one, final pivotal data for Captisol-enabled Melphalan will be available in quarter two with a filing thereafter. Number two, we will fully enroll the phase-II study of SPI-2012, our novel long-acting granulocyte colony-stimulating factor, and make a go-no-go decision for phase-III. Number three, we await the FDA's decision on approval of Beleodaq on August 9. Number four, our plan is to file the New Drug Application for Apaziquone and start another phase-III based on the learnings from previous studies. Number five, we will continue to enroll patients in three phase-III programs - the OPTIMAL trial of Marqibo in diffuse large B-cell lymphoma; the HALLMARQ trial of Marqibo in frontline acute lymphoblastic leukemia; and the phase-III ZEST study evaluating Zevalin in diffuse large B-cell lymphoma consolidation. All three of the studies focus on areas of great unmet need and they target large patient populations."
Source: Q4 2013 earnings conference call, 3/06/14.

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Ken Keller, EVP, Chief Operating Officer, commented on the path forward for Apaziquone in Bladder cancer. He stated, "As we have previously stated, we intend to file a new drug application for Apaziquone in 2014. That will be our third NDA in the next 18 months. Currently, we are awaiting input from the FDA on the protocol design for a new supportive study. The final data will be submitted to the FDA following completion of their NDA review."
Source: Q1 2013 earnings conference call, 5/09/13.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Apaziquone (Eoquin)UrologyBladder cancerAlkylating agent (prodrug)DNA

Mechanism of action: Eoquin, a SM, causes DNA damage and cell death via the direct alkylation of DNA. Bladder tumor cells have high levels of the enzyme DT-diaphorase, an enzyme that activates Eoquin.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-12-11

Results: Pending