Jul 17 MERCK ONCOLOGY

Oncology Highlights – 30/07/2018

Keytruda, the First Anti-PD-1 Therapy for Advanced Melanoma, Approved in China

Merck announced that Keytruda, Merck’s anti-PD-1 therapy, has been approved by the China National Drug Administration (CNDA) for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy. This is the first and only approval of an anti-PD-1 therapy for advanced melanoma in China. Advanced melanoma is one of the cancers that has been most responsive to immunotherapy, and outside of China, anti-PD-1 therapies such as pembrolizumab have become the standard therapy for this disease. With the approval of pembrolizumab in China, the treatment of advanced melanoma will now be aligned with international standards.

The approval of Keytruda in China was based on overall response rate (ORR) data from the phase Ib KEYNOTE-151 study, which evaluated Keytruda monotherapy in Chinese patients with previously treated locally advanced or metastatic melanoma who received one prior line of systemic therapy. In 2018, the CNDA granted priority review status to Keytruda, which accelerated the approval process by allowing for simultaneous clinical validation for the first time creating an industry leading approval turnaround time for imported cancer medicine in China. The approval of Keytruda in advanced melanoma marks the sixth new product approval for MSD China in 2018.

Dr. Reddy’s Laboratories Launches Hervycta (trastuzumab biosimilar) in India For The Treatment of HER2-Positive Cancers (early breast cancer, metastatic breast cancer and metastatic gastric cancer)

Dr. Reddy’s Laboratories has launched Hervycta (trastuzumab), a biosimilar of Roche’s Herceptin, in India, indicated for the treatment of HER2-positive cancers (early breast cancer, metastatic breast cancer and metastatic gastric cancer). Dr. Reddy’s Hervycta is available in strengths of 150mg and 440mg multiple dose vials. According to Ipsos, Herceptin (marketed as Herclon in India) and its biosimilars had India sales of approximately INR 290 Crore MAT for the most recent twelve months ending in December 2017. Dr. Reddy’s currently has four biosimilar products commercialized in India and various emerging markets, and an active pipeline of several biosimilar products in the oncology and immunology space.

Novartis Kisqali Gets FDA Approval for New Breast Cancer Therapy

Novartis announced a new approval for Kisqali (ribociclib) from the US FDA for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women in the US, and also is indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women. FDA reviewed this supplemental New Drug Application (sNDA) under its Real-Time Oncology Review and Assessment Aid pilot programs and approved the application in less than one month after submission.

This approval is based on the pivotal MONALEESA-7 and MONALEESA-3 phase III clinical trials that demonstrated prolonged progression-free survival (PFS) and improvements as early as eight weeks for Kisqali-based regimens compared to endocrine therapy alone.

FDA Approves Tibsovo, for Acute Myeloid Leukemia

Agios announced that Tibsovo (ivosidenib) was granted approval from the U.S. FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. Tibsovo, an oral, targeted inhibitor of the IDH1 enzyme, is the first and only FDA-approved therapy for patients with R/R AML and an IDH1 mutation. Agios’ Tibsovo was approved based on positive phase III data that showed patients on the drug achieved a combined complete remission (CR) and complete remission with partial hematologic improvement (CRh) rate. Trial data showed a CR+CRh rate of 32.8 percent. The CR rate was 24.7 percent (43 of 174 patients) and the CRh rate was 8 percent.

Merck’s sBLA for Keytruda Receives Priority Review from US FDA for Advanced Hepatocellular Carcinoma Treatment

Merck has announced that the U.S. FDA granted Priority Review for a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with Advanced Hepatocellular Carcinoma (HCC). This sBLA, which is seeking accelerated approval for this new indication, is based on data from the phase II KEYNOTE-224 trial, which were recently presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The Lancet Oncology.

The apex drug regulator has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Nov. 9, 2018.

Incidence of Advanced Hepatocellular Carcinoma is constantly on the rise in all the major geographies of the world. According to DelveInsight, a premier healthcare market research & consulting firm based at New Delhi of India, the total cases of the disease in the major regions of the world are going to reach around 490,120 by 2027.

US FDA Grants Priority Review to Merck’s sBLA for Keytruda as First-Line Treatment for Metastatic Squamous Non-Small Cell Lung Cancer

Merck has announced that the U.S. FDA accepted the proposal for reviewing a supplemental Biologics License Application (sBLA) for KEYTRUDA, the company’s anti-PD-1 therapy, based on results of the phase III KEYNOTE-189 trial. The application seeks approval for KEYTRUDA in combination with pemetrexed (ALIMTA) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).

The FDA has granted Priority Review to this sBLA and also set a Prescription Drug User Fee Act (PDUFA), or target action, date of Sept. 23, 2018. Notably, this would mark the third indication for KEYTRUDA in metastatic NSCLC in the United States based on OS data, if the FDA approves.

Abcam and Merck Collaborate to Produce New PD-L1 Antibody for Immuno-Oncology Research

Abcam has announced the commercial launch of the new anti-PD-L1 antibody clone MKP1A07310 (clone 73-10), developed in collaboration with Merck KGaA, Darmstadt, Germany.

Developed by Abcam for use by Merck as an analytical antibody to support Merck’s therapeutic programme running for several years now, this new clone has been created by Abcam’s in-house antibody engineers, who specialise in the discovery and development of challenging antibodies.

The antibody is important in assessing the expression of PD-L1 in tumors of patients who might be able to benefit from PD-1/PD-L1 checkpoint immunotherapy.

FDA Grants Breakthrough Therapy Designation for Roche’s Tecentriq in Combination with Avastin as First-Line Treatment for Advanced or Metastatic Hepatocellular Carcinoma (HCC)

The US FDA has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer. The designation is based on data from a phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin. This is the 22nd Breakthrough Therapy Designation for Roche’s portfolio of medicines and the 3rd for Tecentriq.

USFDA Grants Approval to Sun Pharma’s Cancer Treatment Injection

Sun Pharmaceutical has received approval from the US health regulator for its INFUGEM injection used for the treatment of cancer. This is the first US FDA approval for a product from the company’s Halol facility after the receipt of Establishment Inspection Report (EIR) in June 2018. The US FDA approval is for INFUGEM injection (gemcitabine in 0.9 per cent sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer bag. The technology used to formulate INFUGEM eliminates the risks associated with compounding, an extra step in the administration of cytotoxic infusion products, providing improved safety for healthcare professionals and cancer patients. As per IQVIA, the addressable market size is approximately $35 million for the 12 months ending March 2018. INFUGEM uses a proprietary technology which allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in RTA infusion bags.

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