FDA Validates Use of Amgen’s KRAS Inhibitor in Lung Cancer 

In a pathbreaking move, Amgen has gone ahead to emerge as a trailblazer in the undruggable lung cancer space with the approval of its KRAS inhibitor, Lumakras. For eons, the researchers grappled to come up with an effective and potential drug to target cancers with KRAS mutations. However, Amgen finally managed to put a full stop to the woes. 

Lumakras (sotorasib) received approval for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The recommendations came using the Accelerated Approval pathway based on the results from the largest clinical trial, CodeBreaK 100,  conducted to date exclusively for patients with the KRAS G12C mutation.

Each year,  over 2 million people report for new lung cancer diagnoses, out of which approximately 84% of the cases report NSCLC with KRAS G12C as one of the most prevalent driver mutations. To date, the unmet needs in the NSCLC market reportedly remain huge with only a limited number of treatment options; however, with Amgen’s commitment to benefit NSCLC patients, the treatment gap appears to close a bit. 

Verrica Pharmaceuticals’ Skin Disease Treatment & Delays in Approval 

Verrica Pharmaceuticals, a West Chester-based dermatology company developing therapeutics to bridge the treatment hollows in the skin disease market, is for long now struggling to assure the US drug regulatory agency of the efficacy and potential of its lead candidate VP-102. 

The drug is in the development for the treatment of molluscum contagiosum, or molluscum, a highly contagious and primarily pediatric viral skin disease, and common warts. The company originally submitted the NDA for the drug in September 2019 and the FDA issued a complete response letter (CRL) in July 2020. The company resubmitted the NDA with the requested data, expected a response by June 2021, which is now extended by three months.

At the moment, there is no approved standard of care in the molluscum contagiosum market, suggesting a bright opportunity for the company to grab the share post-approval. The company also plans to proceed with a phase II trial for its another asses VP-103 for the treatment of plantar warts. 

Fennec Takes Another Shot at its Chemotherapy-Induced Hearing Loss Drug

Fennec Pharmaceuticals, a speciality pharmaceutical company, is devoting itself to develop and commercialize its drug PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients with chemotherapy-induced hearing loss.

The therapy, PEDMARK is a unique formulation of sodium thiosulfate for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.

The company is now resubmitting the NDA to the USFDA after receiving a CRL, which requested more data owing to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data.

Nexturn Bio Inc. Gets a Hold of a 50% stake in RosVivo Therapeutics

Nexturn Bio, a subsidiary of Nexturn Bioscience Co., Ltd., acquired a 50% stake in RosVivo Therapeutics Inc. (“Rosvivo”) by shelling out 5.5 million U.S. dollars. The move of Nexturn Bio seems to help bolster its pipeline portfolio with the help of RosVivo’s miRNA technology.

The duo plans to develop drugs to target diabetes, obesity, non-alcoholic fatty liver disease (NAFLD), gastrointestinal (GI) dysmotility, and COVID-19.

RosVivo Therapeutics’ innovative miRNA drug RSVI-301 signficantly lowers down the  injection frequency, prolongs effect, and alleviates side effects in Diabetes, as shown in pre-clinical trials. Once approved, it will earn the tag of the first miRNA-based therapy that targets diabetes and COVID-19.

Thus, the decision of Nexturn backed by several KOLs in endocrinology and gastroenterology is expected to give the company an advantage in the Diabetes market