On October 13, 2014 Pfizer reported that the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA) (Press release Pfizer, OCT 13, 2014, View Source [SID:1234500826]). This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015.

Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer.

"If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the U.S. who are living with metastatic breast cancer," said Garry Nicholson, president, Pfizer Oncology. "We look forward to continuing to work closely with the FDA through the review process."

Pfizer recently announced the initiation of a multi-center, open-label expanded access program (EAP) in the United States for palbociclib. Through the program, palbociclib is available to post-menopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer who are eligible for letrozole therapy and for whom enrolling in other palbociclib clinical trials is not an option. Healthcare professionals and patients can learn more about the palbociclib EAP by visiting www.clinicaltrials.gov (trial number: NCT02142868).

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On October 10, 2014 Oxford BioMedica reported that it has signed further contracts with Novartis which build on the collaboration with Novartis announced in May 2013 (Press release Oxford BioMedica, OCT 10, 2014, View Source [SID:1234500821]).

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Under the terms of the new agreement, Novartis will pay $14 million upfront including a $4.3 million equity subscription for a non-exclusive worldwide development and commercialisation licence in oncology under the Group’s LentiVector platform. OXB will manufacture lentiviral vectors expressing CTL019/CART-019. The manufacturing contract has an initial three year term. Additionally, OXB has granted Novartis an exclusive licence for the worldwide development and commercialisation of all Chimeric Antigen Receptor (CAR) T cell products arising from the process development collaboration.

According to the terms of the deal, OXB is eligible to receive up to $90 million from Novartis over the next three years. This amount includes the upfront licence payment, the equity investment, manufacturing and process development services and various performance incentives. The equity investment comprises 70,807,500 ordinary shares at 3.8p, the average middle market price for the 10 business days prior to 7 October 2014. OXB will also receive undisclosed royalties on potential future sales of CTL019 and other CAR T cell products covered by the agreement.

Commenting on the announcement, John Dawson, Chief Executive Officer of Oxford BioMedica, said:

"We are delighted to sign a second agreement with Novartis. Oxford BioMedica now has a breadth of leading capabilities in gene and cell therapy under-pinned by a dominant LentiVector patent estate (licensed to multiple companies), and a state-of-the-art GMP manufacturing facility. Today’s commitment from Novartis, including their equity investment, strongly endorses this. Our team has demonstrated its ability to solve complex gene and cell therapy manufacturing challenges, and to develop the state-of-the-art analytics essential for such programmes.

"Oxford BioMedica aims to help facilitate access to life changing treatments for many more patients with a variety of clinical indications and is now strongly positioned to deliver significant value-creating results against its strong asset base."

On October 10, 2014 Ipsen reported positive results from the phase III study of triptorelin pamoate 11.25 mg (Decapeptyl 3 months) administered subcutaneously in patients with locally advanced or metastatic prostate cancer at the European Association of Urology (EAU) 14th Central European Meeting in Cracow, Poland (10-12 October 2014) (Press release Ipsen, OCT 10, 2014, View Source [SID:1234500820]).

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The primary objective of the study was to assess the efficacy and safety profile of the sustained-release triptorelin pamoate 11.25 mg (Decapeptyl 3 months) formulation when administered by the subcutaneous route in men with locally advanced or metastatic prostate cancer. This objective was met with castration levels of testosterone achieved in 97.6% [95% CI: 93.2-99.5] of men at week 4 and castration maintained in 96.6% of these men [95% CI: 91.6-99.1] at week 26.

Mean testosterone levels decreased to 18.4 ng/dl and 10.2 ng/dl at week 4 and week 8,
respectively, and remained within this range until the end of the study. Median time to achieve
castration was 22 days. For more than 90% of the patients, the level of testosterone was
maintained below 20 ng/dl from week 8 up to the end of the trial.

Median Prostate Specific Antigen (PSA) levels were reduced by 64.2% and 96.0% at week 4
and week 26, respectively. PSA levels remained within the normal range (0–4 ng/ml) from week 8 until the end of the study.

On October 9, 2014 GenSpera reported that patient enrollment has been completed in the company’s Phase II clinical trial in patients with liver cancer (hepatocellular carcinoma) (Filing 8-K , GenSpera, OCT 10, 2014, View Source [SID:1234500819]). Formal results of the study are expected to be available during the first quarter of 2015.

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"We are grateful to the trial investigators for their efforts, as well as the patients and their loved ones who are supporting this important trial," said Craig Dionne, PhD, GenSpera’s CEO. "The completion of the enrollment period for this trial marks another company milestone. The data we have collected to date establish proof of concept for mipsagargin’s destruction of blood vessels within tumors and encouraging signs of potential anti-tumor activity. We anticipate similar results in our ongoing Phase II trials in patients with glioblastoma as well as our planned Phase II trial in patients with prostate cancer."

Interim data from the ongoing Phase II clinical trial in liver cancer patients were recently presented at the Asia Pacific Primary Liver Cancer Expert Meeting in Taipei in July 2014 (APPLE2014) and at the International Liver Cancer Association (ILCA) meeting in Kyoto in September 2014. Impressively, 80% of liver cancer patients in the Phase Ib and Phase II studies experienced disease stabilization at two months and a significant percentage of patients had stable disease for at least nine months after beginning treatment with mipsagargin.

The US Food and Drug Administration (FDA) granted Orphan Drug designation in 2013 for the evaluation of mipsagargin in patients with hepatocellular carcinoma.